Delegate pack (PDF 2.43Mb) - Systems
Transcription
Delegate pack (PDF 2.43Mb) - Systems
63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 1 Connecting for Health Digital Information Policy Setting the direction for Information Governance Delegate Pack 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 2 Connecting for Health Digital Information Policy Contents Page Introduction 4 Speaker Biographies 6 The UK Council of Caldicott Guardians 12 The National Information Governance Agenda 14 Cabinet Office: Data handling review 14 The Information Commissioner’s Office 15 The NHS Information Governance Assurance Programme 16 • Communications from David Nicholson and Matthew Swindells 16 • The NHS IG Assurance Programme closure report 18 • The Chief Information Officer for Health 19 • The Department of Health: Digital Information Policy team 19 • The National Information Governance Board 20 • The Ethics and Confidentiality Committee of the NIGB 22 • The Electronic Social Care Records Implementation Board 22 The NHS Information Governance Assurance Framework 24 • What is the NHS IG Assurance Framework? 24 • The NHS Operating Framework for 2009/10 24 • Responsibilities for all NHS Providers (including the PCT provider function and general practice) 25 • Responsibilities for PCT Commissioners 26 • Responsibilities for Strategic Health Authorities 26 • The Information Governance Toolkit 26 • The NHS Connecting for Health IG Statement of Compliance 27 • The NHS Care Record Guarantee 27 • IG Education, Training and Development 28 • The IG Training Tool 28 • Other IG qualifications - Foundation Degree 32 • Experiences on the IG Masters course 35 1 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 3 Connecting for Health Digital Information Policy Information Sharing 37 • Richard Thomas and Mark Walport: Data sharing review 37 • Ministry of Justice: Response to data sharing review 41 • Case studies: Queries responded to by the UK Council of Caldicott Guardians 44 Links and Contacts 47 • Departments and Bodies 47 • Products and Services 47 • Publications 48 • Helpdesk contacts 49 2 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 4 Connecting for Health Digital Information Policy Appendices 51 Appendix A: The UK Council of Caldicott Guardians 53 1. Constitution 55 2. Strategic work-plan 59 Appendix B: The National Information Governance agenda 69 1. Cabinet Office: Data handling review 71 2. David Nicholson's letter 4 December 2007 115 3. David Nicholson's letter 15 January 2008 119 4. Matthew Swindells' letter 30 January 2008 123 5. Matthew Swindells' letter 29 February 2008 125 6. David Nicholson's letter 20 May 2008 133 7. David Nicholson's letter September 2008 139 8. Information Governance Assurance Programme: Closure Report 145 9. Ministry of Justice consultation on the Information Commissioner’s inspection powers and funding arrangements under the Data 205 Protection Act 1998 Appendix C: The NHS Information Governance Assurance Framework 237 1. The NHS Operating Framework for 2009/10 239 2. Informatics Planning 2009/10 291 3. The NHS Care Record Guarantee 321 4. IG Serious Untoward Incident Checklist 341 Appendix D: Information Sharing 357 1. Richard Thomas and Mark Walport: Data sharing review 359 2. Ministry of Justice: Response to data sharing review 551 Appendix E: Separate publications 579 1. Caldicott Guardian Manual 2006 2. Confidentiality: NHS Code of Practice 2003 3. The National Information Governance Board: Annual report 3 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 5 Connecting for Health Digital Information Policy Introduction We have great pleasure in welcoming you to the National Information Governance Conference 2009. The conference is a key delivery area from the strategic work-plan of the UK Council of Caldicott Guardians, it follows training needs analyses carried out for Caldicott Guardians and IG leads during 2007 in which a national conference was one of the preferred methods of training delivery. The title of the conference is “Setting the Direction for Information Governance”. As we all know the profile of Information Governance has risen exponentially over the past 18 months, therefore, the overall aims of the conference are to: • Raise awareness of the evolving role of the Caldicott Guardian and how Caldicott Guardianship fits into the wider Information Governance agenda. • Inform delegates of national developments in Information Governance Assurance and the effect on NHS and social care organisations. • Ensure delegates recognise the impact and applicability of the National Programme for IT to their role. • Assist delegates to identify sources of support and advice. Many of you will be experienced Caldicott Guardians and IG professionals working at the sharp end of implementation and with a deeper insight into what works and what is achievable and sustainable. Therefore, this conference is also an opportunity for you to ensure that your views are heard at a national level, to network with likeminded colleagues and to help ensure that we are all heading in the correct direction at an achievable and sustainable pace. There are a range of excellent speakers on today’s programme and the Council would like to thank all of them for taking time out of their busy schedules to participate in the conference. In view of its name and purpose, the Council is especially pleased to welcome Dame Fiona Caldicott, Principal at Somerville College, University of Oxford. The conference will be chaired by Stephen Hinde, outgoing Chair of the UK Council of Caldicott Guardians. The keynote address is being delivered by the new Chief Information Officer for Health, Christine Connelly. Our other morning speakers are the Information Commissioner, Richard Thomas; David Johnstone, Chair of the Electronic Social Care Records Implementation Board; Harry Cayton, Chair of the National IG Board for Health and Social Care; and Phil Walker, Head of Digital Information Policy, Department of Health. 4 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 6 Connecting for Health Digital Information Policy The afternoon is comprised of a series of workshops/seminars covering topical matters such as information risk management, implementing information governance in social care and the secondary use of personal data, the latter will be facilitated by Professor Dame Joan Higgins, Chair of the Ethics and Confidentiality Committee of the NIGB. An evening seminar titled “Information Governance as a profession” will take the form of a discussion on developing and promoting information governance as a professional discipline. Topic areas will include the practical evolution of IG, the career progression framework and the creation of a professional body for IG staff. We hope that you enjoy the conference and that you leave with ideas and methods that you can apply to your own practice, and with contacts and sources of advice that will be of assistance as you continue in your IG role. UK Council of Caldicott Guardians Digital Information Policy team 5 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 7 Connecting for Health Digital Information Policy Speaker Biographies Stephen Hinde Group Information Protection Manager & Caldicott Guardian, Bupa Group Stephen Hinde is Chairman of the UK Council of Caldicott Guardians, who he represents on the National Information Governance Board for Health & Social Care. He represents Caldicott Guardians on the Scottish Information Governance Managed Knowledge Network Steering Group. Stephen is Chairman of the Data Protection Panel of the Association of British Insurers, Chairman of the Confidentiality Working Group of the Independent Healthcare Advisory Service, and Chairman of the Private Medical Insurance Companies Confidentiality Forum. He is ex officio a member of the Financial Crime Committee of the Association of British Insurers. He has been involved in Data Protection since the early 1980s, and has lectured and written extensively on Data Protection, Business Resumption Planning, Computer Security, Computer Audit and Internal Audit. Stephen is the Group Information Protection Manager & Caldicott Guardian for the Bupa Group with responsibility to protect all parts of the Bupa Group from misuse or misappropriation of patient, member or client confidential information. He also Chairs Bupa’s Information Governance Committee. Stephen is Chairman of the Professional Education and Qualification Committee of the Faculty of Information Technology, Institute of Chartered Accountants in England and Wales (ICAEW); Past President, Institute of Internal Auditors - UK and Ireland (IIA-UK); Founding Editor, Computer Audit Update and Information Systems Auditor; Computer Audit Editor, Computers and Security Journal; and was a regular contributor to Computer Fraud & Security. He has also chaired, or been a member of various education, training and research committees of ICAEW, IIA - UK, IIA Inc., and the European Confederation of Institutes of Internal Auditing. He is an examiner in advanced computer audit for IIA - UK, and was an examiner for the Advanced Case Study for ICAEW. Stephen is a member of BSI Technical Committee IST-35 - Health Informatics. He has held senior audit positions with various international accounting firms and multinationals in a range of industries including consumer electronics, food, leisure and health care. 6 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 8 Connecting for Health Digital Information Policy Dame Fiona Caldicott Principal of Somerville College, Oxford In the University of Oxford, Dame Fiona is a Pro-Vice-Chancellor with specific responsibility for Personnel and Equality, a member of Council, and chairman of the Personnel Committee. She was Chairman of the Conference of Colleges from 2003 - 2005. She is an Honorary Consultant Psychiatrist, having been Consultant and Senior Clinical Lecturer in Psychotherapy for the South Birmingham Mental Health NHS Trust. She has worked as a Unit General Manager, and as Clinical and Medical Director in that Trust. She is the Acting Chairman and a Non-Executive Director of the Oxford Radcliffe Hospitals NHS Trust. She was a Trustee of the Nuffield Trust from 1999-2008 and is currently a Trustee of the Daphne Jackson Trust. She has recently completed a term as President of the British Association for Counselling and Psychotherapy. As President of the Royal College of Psychiatrists (1993-1996), she was also chairman of the Academy of Medical Royal Colleges (1995-1996). From 1996-1997 she chaired the Caldicott Committee on patient identifiable data for the National Health Service Executive, the recommendations of which have been implemented. Also from 1996-1998, she chaired a working group of the Nuffield Council on Bioethics that produced a report on Genetics and Mental Disorder. Christine Connelly Chief Information Officer, Department of Health Christine Connelly is the first Chief Information Officer for Health and will focus on developing and delivering the Department’s overall information strategy and integrating leadership across the NHS. She took up post in September 2008. Christine was CIO at Cadbury Schweppes from May 2004 to September 2007. Prior to joining Cadbury Schweppes, Christine worked in various global roles at BP. Her career included the senior IT position for both the Exploration & Production and Refining & Marketing businesses as well as leadership roles in Business Simplification, Technology, Innovation, Internal Audit and General Management. Her last position in the company was as Chief of Staff for the Gas, Power & Renewables business. Christine was born in Scotland and has a degree in Computer Science from Aberdeen University. 7 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 9 Connecting for Health Digital Information Policy Harry Cayton Chair of the National Information Governance Board for Health and Social Care Harry Cayton has been chief executive of the Council for Healthcare Regulatory Excellence since August 2007. He was formerly National Director for Patients & the Public at the Department of Health. From 1992 to 2003 he was chief executive of the Alzheimer’s Society and from 1981 to 1992 Director of the National Deaf Children’s Society. He is chair of the National Information Governance Board for Health and Social Care, Co-Chair of National Voices, an advisor to The Health Foundation and to Macmillan Cancer Support and a trustee of Comic Relief. Harry has written many articles and book chapters and his co-authored book for carers and people with dementia has been published in eight languages. He is a regular speaker at national and international conferences. He was awarded the OBE in 2001 for services to people with dementia. He received the Alzheimer Europe Award in 2004, and was Distinguished Graduate of the University of Ulster 2005. In 2007 he received a Lifetime Achievement Award from the Royal College of Psychiatrists and a Fellowship through Distinction from the Faculty of Public Health. David Johnstone Chair of the Electronic Social Care Record Implementation Board David Johnstone is Executive Director of Adult & Community Services in Devon and is a member of the Executive Council of the Association of Directors of Adult Social Services. He is extensively involved in the development of electronic care records in health and social care, as a board member of the National Programme for IT and co-chairperson of the Electronic Social Care Record Implementation Board. He has been recently appointed to the NHS Clinical Advisory Team. Phil Walker Head of Digital Information Policy, NHS Connecting for Health Phil Walker supported the Caldicott Committee during 1996/97 and was responsible for implementing the recommendations of the Committee, including the introduction of Caldicott Guardians into the NHS and Social Care providers. Phil was also the principal author of the Department of Health’s strategy for protecting and using patient information published in 2001. This strategy established the concept of information governance in the NHS and is the basis for the confidentiality architecture for the NHS that is now being implemented through the National Programme for IT. Phil currently heads a policy team that develops policy across the broad information governance agenda and is leading work to deliver an information governance assurance framework for all parts of the NHS and its business partners. 8 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 10 Connecting for Health Digital Information Policy Richard Thomas The Information Commissioner Richard Thomas has been the Information Commissioner since November 2002. His term of office has been extended until June 2009. He is appointed by HM Queen and has independent status, reporting directly to Parliament, with a range of responsibilities under the Freedom of Information Act 2000, the Data Protection Act 1998 and related laws. The functions of the Information Commissioner’s Office (ICO) include promoting good practice, ruling on complaints and taking regulatory action. Richard's previous career has included: • Director of Public Policy at Clifford Chance; • Director of Consumer Affairs at the Office of Fair Trading; • Head of Public Affairs and Legal Officer at the National Consumer Council; • Solicitor with the Citizens Advice Bureau Service and Freshfields Bruckhaus Deringer. He has also previously held various public appointments, including membership of the Lord Chancellor’s Civil Justice Review Advisory Committee and the Board of the Financial Ombudsman Service. Richard has been awarded an honorary Doctor of Laws degree by the University of Southampton and is a visiting Professor at the University of Northumbria. He has been married to Julia since 1974 and they have three adult children. Alistair Donaldson NHS Information Security Policy Manager, NHS Connecting for Health Alistair Donaldson is the Department of Health official responsible for NHS Digital Information Security and Risk Management Policy. He is a member of the Digital Health and Information Policy Directorate within NHS Connecting for Health providing support to Ministers, Management and strategic advisory groups. In addition, he regularly chairs both the UK E-health Information Security Liaison Group involving NHS England, Scotland, Wales, NI, Isle of Man Govt and Ministry of Defence, and the NHS CFH Information Security Management Forum involving key commercial services providers and systems integrators to the NHS National Programme for IT. Alistair is a member of several UK government information security and assurance committees working closely with Cabinet Office, the Centre for the Protection of the National Infrastructure, CESG and others representing the NHS on a range of information assurance topics. 9 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 11 Connecting for Health Digital Information Policy James Wood Head of IT Security, NHS Connecting for Health James Wood is the Head of IT Security within the NHS Connecting for Health (CFH), Technology Office. His main focus is with Infrastructure and Information Security Assurance and he leads a team of security subject matter experts focussed on the delivery of security into the National Programme for IT and the NHS. James is managing the development of the NHS Public Key Infrastructure (PKI) and is chairperson for the Policy Management Authority which oversees its ongoing operation and management. In addition, James represents NHS CFH on a number of Pan Government working groups including Secure File Transfer, Vulnerability Assessment and cross government networking and he also provides advice and direction to the CREST Industry Advisory Panel. Professor Dame Joan Higgins Chair of the Ethics and Confidentiality Committee of the NIGB Professor Dame Joan Higgins has held the positions of Professor Emerita of Health Policy, University of Manchester and Professor of Social Policy at the University of Southampton. She has chaired the national Patient Information Advisory Group, now the Ethics and Confidentiality Committee of the NIGB, since it began. Joan has been a non executive director in the NHS for over 20 years and was Chair of the Christie NHS Trust from 2002 until 2007. Joan was appointed as Chair of the NHS Litigation Authority (NHSLA) in January 2007. Ben Heal UK Council of Caldicott Guardians Ben Heal is a founder member of the UK Council of Caldicott Guardians on which he represents the Social Care sector. He is the Caldicott Guardian for Adults and Children’s Services at Sefton Council in the Health and Social Care Department. He has been Caldicott Guardian for 5 years and is also the lead welfare emergency planner for the Council. 10 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 12 Connecting for Health Digital Information Policy David Riley UK Council of Caldicott Guardians David Riley is one of the Social Care representatives on the UK Council of Caldicott Guardians. He is the Information Governance Manager and Caldicott Guardian for the London Borough of Greenwich, and has been Caldicott Guardian since February 2002. David is actively engaged in the Council ESCR Project, eSAP, CAF and other IT supported projects dealing with sensitive personal information for both Adults and Children. David has worked for Greenwich Social Services Department for 15 years starting as Head of Strategic & Management Support Services. He has a managed range of functions including: Information & Advice Services, Research & Planning, Press & Public Relations, Information Management & Performance Review, Community Care Finance, Protection of Property and administration and management support. He previously worked for Lewisham Council for 15 years where he was a founder of the Policy & Performance Review Network (now the Policy Network), and chaired the Steering Group during its transition to a Ltd Company and Registered Charity. 11 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 13 Connecting for Health Digital Information Policy The UK Council of Caldicott Guardians A Caldicott Guardian is a senior person responsible for protecting the confidentiality of patient and service-user information and enabling appropriate information-sharing. The Guardian plays a key role in ensuring that NHS, Councils with Social Services Responsibilities and partner organisations satisfy the highest practical standards for handling patient identifiable information. Acting as the 'conscience' of an organisation, the Guardian actively supports work to facilitate and enable information sharing and advise on options for lawful and ethical processing of information as required. The Caldicott Guardian also has a strategic role, which involves representing and championing Information Governance requirements and issues at Board or management team level and, where appropriate, at a range of levels within the organisation's overall governance framework. The UK Council of Caldicott Guardians is an elected body made up of Caldicott Guardians from health and social care. It was established in 2005 following work carried out by Janine Brooks, Caldicott Guardian of the former NHS Information Authority. The Council meets four times per year. The Council has formal terms of reference which include the following objectives: • To be the national body for Caldicott Guardians. • To promote the roles and activities of Caldicott Guardians within the United Kingdom. • To be a forum for the exchange of information, views and experience amongst all Caldicott Guardians. • To seek, consider and to represent the views of Caldicott Guardians on matters of policy relating to the organisation and delivery of Information Governance. • To be a channel of communication upon Caldicott matters with national organisations concerned with the NHS, the independent health sector, local government and health and social care professionals. • To act as a resource centre, provide support and arrange learning opportunities for Caldicott Guardians, both current and of the future. The full terms of reference are available in the Council's Constitution document (see Appendix A). 12 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 14 Connecting for Health Digital Information Policy Members of the Council demonstrate a commitment to Caldicott Guardianship, to protecting and appropriately sharing personal information, and are prepared to develop and maintain links with their constituent sector and with other national organisations to ensure that the work of the Council is broadly disseminated. The Council has committed to a work plan, (see Appendix A) which includes education and training development, improving and developing communications to raise the profile of Caldicott Guardians, and providing access to advice and guidance. The work to date has encompassed reviewing papers, training materials and consultations, preparing responses for Caldicott queries (see page 44), submitting articles for the Caldicott Guardian newsletter and representing the Council on the National IG Board and at external events. The Council’s website contains all its published materials which can be viewed at: http://www.connectingforhealth.nhs.uk/systemsandservices/infogov/caldicott At the time of writing, elections are being held for new Council members. However, the current members of the council are: • Chairman: Mr Stephen Hinde, Group Information Protection Manager, Bupa • Vice Chair: Dr Stephen Watkins, Director of Public Health, Stockport PCT • Dr. Stella Clarke, Association of Medical Directors Fife NHS • Dr. Tom Dening, Medical Director, Cambridgeshire & Peterborough Mental Health Partnership NHS Trust • Ms. Stephanie Ellis, Chair of Camden and Islington Community NHS Local Research Ethics Committee • Dr. Elizabeth Fellow-Smith, Medical Director, West London Mental Health NHS Trust • Mr. Ben Heal, Caldicott Guardian, Sefton Social Services • Professor Dame Joan Higgins, Chair of the Ethics and Confidentiality Committee of the NIGB • Dr Alex Horne, Medical Director, North East London NHS Foundation Trust • Dr. Emyr Wyn Jones, Consultant Physician and Medical Director, Doncaster & Bassetlaw Hospitals NHS Foundation Trust • Dr Alison McCallum, Director of Public Health and Health Policy, NHS Lothian • Dr Lorna Ramsay, Associate Specialist PHM (Health Informatics), ISD Clinical Lead for eHealth, National Clinical Dataset Development Programme (NCDDP), & NHS Scotland Information Governance Programme • Mr. David Riley, Information Governance Manager and Caldicott Guardian, London Borough of Greenwich • Dr. Guy Turner, Consultant Anaesthetist / Caldicott Guardian, Royal West Sussex NHS Trust • Mr. Phil Walker, Deputy Head of Digital and Health Information Policy, NHS Connecting for Health 13 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 15 Connecting for Health Digital Information Policy The National Information Governance Agenda Since late 2007 a series of Government initiatives to obtain assurances around public sector information has greatly raised the profile of Information Governance. Cabinet Office: data handling review Following the data loss, reported by Her Majesty’s Revenue and Customs office in November 2007, the Prime Minister asked the Cabinet Secretary to work with security experts to ensure that all Government departments and their agencies check their procedures for the storage and use of personal data and provide formal assurance on personal information for themselves, their agencies and any organisations they were responsible for. Consequently, the NHS Chief Executive, David Nicholson, initiated an urgent, Information Governance Assurance programme for the NHS (see Information Governance Assurance Programme below). The Interim Report by the Cabinet Office, published on 17 December, summarised action taken across Government, and set out initial directions of reform to strengthen the Government's arrangements. The final report, published in June 2008, summarised the work conducted in Departments to improve data handling and set out how the Government was improving information security by putting in place: • core measures to protect personal data and other information across Government. • a culture that properly values protects and uses information. • stronger accountability mechanisms within Departments, and • stronger scrutiny of performance. The measures put in place, which represented a new set of minimum mandatory standards for Departments, include: • introducing new rules on the use of protective measures, such as encryption and penetration testing of systems. • standardising and enhancing the processes by which Departments understand and manage their information risk, identifying the key individuals responsible for information assets and setting out their responsibilities. • requiring quarterly risk assessment within each Department of the confidentiality, integrity and availability of information. • introducing mandatory training for all staff involved in handling personal data, with training taking place on appointment and reinforced on an annual basis. • requiring the use of Privacy Impact Assessments when introducing new policy or processes that involve the use of personal data. • introducing greater scrutiny and monitoring through the inclusion of information risk in Statements on Internal Control, which are scrutinised by the National Audit Office and through spot checks by the Information Commissioner. 14 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 16 Connecting for Health Digital Information Policy • further enhancing transparency of arrangements, through annual reporting to Parliament on progress and the use of Information Charters which provide clarity to citizens about the use and handling of personal data, and • a range of other measures to improve information security across Government. The report concluded by saying that: “Effective public services depend on information about the people they serve. But in order to command public confidence, that information needs to be safely stored and protected. The Government is determined to take the necessary steps to improve data security. The measures outlined [today] are an important part of that process.” The Information Commissioner’s Office The Information Commissioner’s Office (ICO) is the UK's independent public body set up to protect personal information and promote access to official information. It is sponsored by the Ministry of Justice. The ICO enforces and oversees the Data Protection Act, the Freedom of Information Act, the Environmental Information Regulations, and the Privacy and Electronic Communications Regulations. Its main functions are: • educating and influencing - promotion of good practice and giving information and advice. • resolving problems - resolution of eligible complaints from people who think their rights have been breached. • enforcing - use of legal sanctions against those who ignore or refuse to accept their obligations. • undertaking research - gaining a deeper understanding of policy and how it affects individuals. The powers of and sanctions available to the ICO have been considered in two recent consultations: • The Thomas/Walport Data Sharing consultation (see Appendix B). • The Ministry of Justice consultation on the ICO’s inspection powers and funding arrangements under the Data Protection Act 1998 (see Appendix B). Additionally, following the publication of the Data handling review (DHR) it is mandatory for Government departments, including NHS organisations, to share details of significant actual or potential losses of personal data with the ICO. 15 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 17 Connecting for Health Digital Information Policy The NHS Information Governance Assurance Programme In line with the Government directive of November 2007 (before the interim Cabinet Office report) the NHS Chief Executive, David Nicholson, initiated an urgent Information Governance Assurance Programme for the NHS. Its remit was firstly to provide assurances regarding the current processing of person identifiable information in line with the requirements of the DHR, secondly to produce an Information Governance Assurance Framework (see page 24) for the healthcare sector and thirdly to provide continuing assurance that sensitive person identifiable information is managed securely and confidentially. The Programme recognised that NHS organisations were already providing some forms of assurance through their submission of the Information Governance Toolkit assessment to the Department of Health. This also included reporting to the Healthcare Commission on standards C9 and C13 of the Standards for Better Health. In order to clarify new and existing requirements, a series of communications was issued to NHS organisations setting out the organisations' responsibilities for information governance and for providing additional assurances on information governance to each strategic health authority (SHAs), or to Monitor, the Independent Regulator of NHS Foundation Trusts. The communications are reproduced in Appendix B. David Nicholson letters: December 2007 and January 2008 The first of these communications was a letter from David Nicholson, sent to all Chief Executives in the NHS (and copied to Monitor), which restated the responsibility and accountability framework already in place for securing effective information governance, and the actions already required by organisations as part of the assurance process. The letter also set out specific requirements for securing data in transfer. Page three of the letter made reference to a checklist of immediate actions to be taken for securing personal data in transit. The checklist was published by NHS Connecting for Health (NHS CFH) in the form of Good Practice Guidelines, which cover the transfer of batched person identifiable data by means of portable electronic media, including: • tapes • floppy discs • removable hard discs • laptop & handheld computers • optical discs - DVD & CD-ROM • solid state memory cards, memory sticks and pen drives David Nicholson followed his initial communication with a letter to SHA Chief Executive's asking them to take immediate actions to ensure patient data was protected across their patch. 16 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 18 Connecting for Health Digital Information Policy The letter clarified the specific requirements for ensuring personal data was protected in transit, including the suspension of all courier and postal transfers of unencrypted patient data unless the transfer was essential to patient care. Interim information was provided on the reporting of data losses and security breaches as serious untoward incidents, and the measures being taken centrally to support the NHS. Matthew Swindells letters: January and February 2008 In late January 2008 Matthew Swindells, the Department of Health's interim Chief Information Officer, wrote a letter to SHA Chief Information Officers (CIOs). The letter formally confirmed that the movement of unencrypted person identifiable data held in electronic format is not permitted in the NHS unless prevention of movement would adversely affect patient care. Additionally, if an organisation decides to store or transfer such data without encryption, a risk assessment must be carried out. The letter also informed CIOs that technical guidance on encryption was being prepared by NHS Connecting for Health. At the end of February 2008, Chief Executives and SHA CIOs were the recipients of a further letter from Matthew Swindells, regarding the defining and reporting of serious untoward incidents. The letter contains a document setting out the reporting arrangements and describes the actions that need to be taken in terms of communication and follow-up when a serious untoward incident occurs. David Nicholson letters: May and September 2008 In May 2008 David Nicholson wrote to Chief Executives and SHA CIOs, with copies to Directors of Finance and Monitor. The letter set out further actions for SHAs regarding review of IG Toolkit scores for PCTs and Trusts and requiring that SHAs have access to information governance subject matter experts. All NHS organisations were required to include information on serious untoward incidents in their annual reports; appoint a board-level Senior Information Risk Owner; and include information assurance in their Statements on Internal Control. Organisations were informed of future actions regarding staff training and potential disciplinary measures for breaches of confidentiality. Annex A of the letter contains information about the reporting of personal data related incidents within annual reports, and Annex B provides guidance on including how risks to information are managed and controlled within the Statement on Internal Control (SIC). A further letter (September 2008) from David Nicholson was written to Chief Executives and copied to SHA CIOs and Monitor. The letter informed organisations to conduct a review to ensure that the policy to encrypt all removable data has been fully implemented. 17 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 19 Connecting for Health Digital Information Policy The letter draws readers' attention to the report of the Cabinet Office Data Handling Review and asks them to review their internal processes against the recommendations in the report; the recommendations are reproduced in Annex 1 of the letter. It also highlights the data sharing review carried out by Richard Thomas (the Information Commissioner) and Mark Walport (the Director of the Welcome Trust). Importantly, the letter sets out a number of actions to be carried out by general practices and PCT responsibility for ensuring the actions are performed. Other areas covered are encryption, serious untoward incidents and the secure destruction of optical media - this includes Write Once (e.g. CD-ROM, DVD-R) and Write Many (e.g. CD-RW, DVD-RW). The NHS IG Assurance Programme: Closure report As the programme had broadly achieved its objectives and reached a natural conclusion, it was decided to close it to ensure that Information Governance returned to a ‘business as usual’ activity and did not rely upon the existence of a transient programme of work. This closure document makes a number of recommendations to facilitate the transition to ‘business as usual’ and to ensure that an appropriate focus on Information Governance is maintained. The report sets out all the actions and activities that have taken place allowing the programme to close, and contains recommendations for the Department of Health, where the programme team and the programme board feel that these are appropriate, in order to ensure that the Department and its constituent organisations can continue to deal effectively with Information Governance issues. The outcomes of the Information Governance Assurance Programme can be summarised as: • The main components of an Information Governance Assurance Framework have been established (see page 24). • The existing NHS policy framework has been strengthened, and clarified to reflect the Cabinet Office Data Handling Review. This has been translated into a clear set of IG requirements applicable to all organisations. • The IG Toolkit has been developed as the principle mechanism by which IG policy can be synthesised into measurable requirements for IG. It demonstrates how organisations can be assessed in terms of performance. Its output will be used to inform not only those concerned with policy, e.g. the NIGB, but also those concerned with assessing performance, including Monitor and SHAs. • The critical importance of compliance with the IG requirements has been firmly established on the agendas of Boards, Audit Committees, executive and non executive Directors. • The requirement for internal audit of IG has been formally established by including IG performance in the Statements on Internal Control, and the potential established to further enhance assurance via external audit. 18 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 20 Connecting for Health Digital Information Policy • The principle regulatory bodies have included IG assurance on their performance assessment and management agendas; most notably the Healthcare Commission, but also Monitor in respect of Foundation Trusts. • The management of information risk has been strengthened by new requirements for Senior Information Risk Owners, and a clarified role for a supporting framework of information asset owners within each major organisation. • A substantial start has been made to the task of building capability and capacity by launching important training initiatives, which have been very well received. This has been done by ensuring that IG is included in the advisory and support material available to Board members. The closure report recognised that capacity and capability is a limiting factor across all organisations in respect of Information Governance. The Chief Information Officer for Health Many of the recommendations in the IG Assurance Programme closure document are now “owned” by the first Chief Information Officer (CIO) for Health, Christine Connelly. Her remit is to focus on developing and delivering the Department of Health's (DH) overall information strategy and integrating leadership to the key informatics organisations inside and outside DH including NHS Connecting for Health, the Information Centre and DH Information Services. The post includes responsibility for information governance and assurance and managing key external stakeholder relationships. The CIO is a member of the NHS Leadership Team and of the DH Corporate Management Board, and has a direct reporting line to David Nicholson (the Chief Executive of the NHS). The Department of Health: Digital Information Policy Team The Digital Information Policy team is part of the Digital & Health Information Policy Directorate of the Department of Health. Based within NHS Connecting for Health, it is comprised of civil servants and NHS staff members. The team’s role is to set policy for the NHS and adult social care in relation to the use of personal and corporate information. This includes the provision of advice, guidance and codes of practice to NHS and adult social care organisations to help them implement the Information Governance agenda. The team is involved in cross-Government work, particularly on ensuring there are appropriate confidentiality and security standards in place when information sharing is being considered. Advice is also provided to members of the public on information governance issues. The team have developed a number of tools and processes to help organisations understand the concepts and requirements of Information Governance and to help them assess and improve compliance. These include the IG Toolkit, the IG Training Tool, attendance at workshops and IG network meetings, and helpdesks. 19 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 21 Connecting for Health Digital Information Policy The National Information Governance Board for Health and Social Care The National Information Governance Board for Health and Social Care (NIGB) is a statutory body formally established by the Health and Social Care Act 2008. The Board’s aim is to provide leadership and promote consistent standards for information governance across health and social care. It will also tackle the ethical and legal interpretation and application of these policies and give advice on matters at national level. The Board reports annually to the Secretary of State for Health and publishes the NHS Care Record Guarantee for England. Members of the Board are either members of the public appointed by the Appointments Commission or represent stakeholders in health and social care information governance. The Chair, Harry Cayton, was appointed by the Secretary of State for Health and is the Chief Executive of the Council for Healthcare Regulatory Excellence. Overall the role of the NIGB is to support improvements to information governance practice in health and social care. Its full terms of reference are to: • provide leadership and promote consistent standards for information governance across health and social care, to enable ethical, legal and policy issues to be appropriately dealt with. • monitor information governance trends and issues through analysis of annual information governance returns from all bodies using or holding NHS or Social Care information. • arbitrate on the interpretation and application of information governance policy and give advice. • have oversight of and advise on the confidentiality management and access control frameworks implemented through the National Programme for IT. • own and review the NHS Care Record Guarantee for England annually. • advise the Secretary of State on any matters of information governance that should be brought to their attention and to produce an annual report to the Secretary of State. • deal with other such matters as required by the Secretary of State and other appropriate bodies, and • work with appropriate bodies, including those in the home countries, on issues within its remit. The NIGB’s remit covers all organisations that gather information as part of the delivery of NHS and adult social care in England. The Board provides both assurance information and advice to the Secretary of State and others of the state of IG practice in the NHS and adult social care. They can provide advice to anyone using personal information gathered for delivery of NHS and adult social care, and additionally can 20 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 22 Connecting for Health Digital Information Policy advise NHS and adult social care organisations even where advice has not be sought. NHS and social care organisations must give due regard to any advice issued as the NIGB can ask for evidence of any compliance steps taken. The NIGB fulfils its remit by providing: • Leadership - Stakeholder organisations represented at the NIGB includes both health and social care organisations and with and through these the NIGB provides leadership and promotes consistent standards for information governance across both health and social care. • Giving patients and the public a voice - Half of the members of the NIGB are members of the public, appointed by the independent Appointments Commission after a public recruitment campaign. The public members ensure that the perspective of patients and the public is taken into account when the board discusses or provides advice or guidance on governance matters. • Advice to care professionals - The NIGB provides advice on the interpretation of policies, guidelines and legislation relating to information governance. The NIGB provides a forum where Caldicott Guardians and information governance boards or committees can seek guidance on the interpretation of legislation, policies and guidelines in situations where they feel unable to decide on the correct action. • Advice to service users and the public - The NIGB owns and reviews the NHS Care Record Guarantee for England • Monitoring and oversight • NHS organisations are required to assess their information governance performance annually using the Information Governance Toolkit. The NIGB oversees the content of the Toolkit and uses the annual returns to monitor information governance trends and issues in the NHS, social care and the independent sector. The NIGB is supporting work to increase the use of the Toolkit within social care. • New IT systems are being implemented in all NHS organisations in England as part of the National Programme for IT. The NIGB maintains an oversight and provides advice on the confidentiality management and access control frameworks which the National Programme for IT uses. • Links with other countries - The devolution of government has led to differences in the way that healthcare and social care services are delivered across the UK. The NIGB works closely with similar boards in Wales and Scotland. The Board has agreed a set of principles that it will use to promote a consistent approach to its decision making and the provision of advice and guidance. 21 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 23 Connecting for Health Digital Information Policy The Ethics and Confidentiality Committee of the NIGB On January 1 2009, the NIGB became responsible for providing advice on issues of national significance involving the use of patient information and for overseeing arrangements created under Section 251 of the NHS Act 2006 (originally enacted under Section 60 of the Health and Social Care Act 2001). These responsibilities were previously administered by the Patient Information Advisory Group (PIAG), and will now be carried out by the Ethics and Confidentiality Committee whose members are primarily drawn from PIAG. Professor Dame Joan Higgins will continue as the Chair of the Committee. Section 251 permits the common law duty of confidentiality to be set aside in specific circumstances for medical purposes. It provides a power to ensure that patient identifiable information needed to support essential NHS activity can be used without the consent of patients. The power can only be used to support medical purposes that are in the interests of patients or the wider public, where consent is not a practicable alternative and where anonymised information will not suffice. The Electronic Social Care Records Implementation Board The ESCR Implementation Board is sponsored by David Behan, Director General for Social Care and jointly chaired by Glen Mason for the Department of Health and David Johnstone for the Association of Directors of Adult Social Services. The Board functions as a sub-group of the national Care Records Service Board. The overall purpose of the ESCR Implementation Board is to: • Develop the Electronic Social Care Record as the national record for social care. • Oversee development and implementation of the Electronic Social Care Record (ESCR); ensuring appropriate links are made with the NHS Connecting for Health Programme and with the Department of Children, Schools and Families (in respect of the children’s social care component of the ESCR). • To contribute to the Communities and Local Government’s information strategy for Local Government. The remit of the Board is to: • Oversee the national implementation of the Electronic Social Care Record. • Ensure consistent implementation of ESCR by Councils with Social Services Responsibilities (CSSR’s) • Coordinate further developments in support of the national ESCR implementation programme, (a) between CSSR’s; (b) between Government Departments and NHS. • Provide a forum for the discussion of policy issues and to resolve problems or where necessary to make recommendations for action through the NHS National Care Records Service Board. 22 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 24 Connecting for Health Digital Information Policy • Ensure that the ethical principles established for the NPfIT are interpreted and applied to the ESCR. • Progress the ESCR development programme within the context of the national development programme for health and social care. • Identify links with other Local Authority information initiatives and advise on development opportunities/potential conflicts arising from them. • Establish a national framework training programme for all users, to encourage consistency in understanding and the implementation of standards in the collection, recording and sharing of information. • Identify and disseminate good practice in social care. • Review ESCR guidance and targets including: • A review of implementation timescales. • Identification of further developments given the range of new initiatives since the publication of ‘Information for Social Care’. The ESCR has the following responsibilities in relation to standards: • Establish national standards for the electronic exchange of information between health, children’s and adult services in support of the implementation of ESCR and other electronic care records and to recommend these to the Department of Health. • Propose Information Governance standards for the ESCR according to the direction of the National Information Governance Board (for England), consistent with the Care Record Guarantee, including the use of common data coding, retention and archiving, role based access and legitimate relationships. • Ensure that the standards for CSSR’s are consistent with the same for the NHS by working with the Health and Social Care Information Standards Board. • In partnership with the Information Standards Board for Health and Social Care to promote information standards and definitions in social care. 23 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 25 Connecting for Health Digital Information Policy The NHS Information Governance Framework What is the NHS Information Governance Assurance Framework? The NHS Information Governance Assurance Framework is “the mechanism by which: • IG policies and standards are set. • regulators can check an organisation’s compliance, and • an organisation can be performance managed.” The Information Governance Assurance Programme: Closure report page 6 The Framework therefore includes annual assessment using the Information Governance Toolkit, completion of the NHS CFH IG Statement of Compliance, organisational compliance with the commitments in the NHS Care Record Guarantee, performance monitoring (by the National IG Board, the Healthcare Commission and Monitor) and internal and, in the future, external audit of the IG standards. In undertaking its work, the NHS Information Governance Assurance Programme developed a number of principles to support Information Governance work going forwards. These principles are as follows: • All NHS organisations, NHS provider organisations, the broader "family" of NHS organisations and the DH and its ALBs should be, as much as possible, part of the same Information Governance Assurance Framework. • Information Governance should be as much as possible integrated into the broader governance of an organisation, and regarded as being as important as financial and clinical governance in organisational culture. • The Framework will provide assurance to the several audiences interested in the safe custody and use of sensitive person identifiable information in healthcare. This involves greater transparency in organisational business processes around Information Governance. • The requirements of the Cabinet Office Data Handling review will be implemented in DH and its ALBs and should, as much as possible, be applied to all NHS organisations. The NHS Operating Framework for 2009/10 The NHS Operating Framework for 2009/10 sets out key priority areas for the service for 2009/10 including the need to focus on the overriding long-term goal of systematically improving quality across the NHS. It restates the requirements set out in the Information Governance Assurance Programme closure report. The use of informatics to support quality is discussed from paragraph 50 on page 30 of the Framework document. The Framework reaffirms the role of robust information governance in maintaining public and patient confidence in the way that the NHS handles all health information, and recognises the progress that has been made to strengthen requirements in relation to secure storage and transfer of patient 24 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 26 Connecting for Health Digital Information Policy identifiable data. The importance of data quality is not overlooked with the recognition that consistent and effective use of NHS numbers and the Personal Demographics Service will reduce the number of mis-associated records and will support the appropriate sharing of patient information with partners in the delivery of patient care. There are a number of requirements placed on the NHS, for example: • All NHS organisations will need to demonstrate compliance with information governance standards through the achievement of a minimum of Level 2 performance against key requirements in the Information Governance Toolkit. • NHS accounting officers are required to report on the management of information risks in Statements on Internal Control from 2008/09 and to include details of data loss and confidentiality breach incidents in annual reports. • Information governance performance, controls and reporting will be subject to audit. Quality and safety of patient care will be improved through better data quality. Data quality metrics for the NHS number, patient demographics, secondary uses and other key priority areas will be routinely published and monitored. Guidance and more detailed expectations are provided in Informatics Planning 2009/10, published alongside the NHS Operating Framework. The supplementary document includes a link to supporting tools for Chief Executives and other key stakeholders, and contains national expectations that should be used by all NHS organisations to refresh and re-focus their informatics plans. The section within the document concerned with Information Governance requires that all bodies that provide or support the provision of NHS services work within the NHS Information Governance Assurance Framework and demonstrate compliance with all key information governance requirements. Expectations are set out separately for: • All NHS providers, including the provider side of PCTs. • PCTs and Care Trusts in their role as commissioners (“PCT Commissioners”). • Strategic Health Authorities. • Responsibilities for all NHS Providers (including the PCT provider function and general practice) • achieve a minimum of Level 2 performance against key requirements published through the NHS Information Governance Toolkit. • actively manage information risks and take all reasonable steps to keep personal information secure. • continue to meet the standards for handling patient personal information set out in the NHS Care Record Guarantee, ensuring that access to information is effectively controlled and that the transfer, use and disclosure of information are subject to effective authorisation procedures. 25 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 27 Connecting for Health Digital Information Policy • support staff through the provision of clear guidance on expected working practices (including cross sector working e.g. for the use of ContactPoint for children’s services) and through annual information governance training. • Responsibilities for PCT Commissioners PCT Commissioners should ensure that all organisations from which care is commissioned, including independent contractors and the third sector, are brought within the NHS Information Governance Assurance Framework. • Responsibilities for Strategic Health Authorities SHAs should ensure patch wide compliance with the requirements of the NHS Information Governance Assurance Framework. Information Governance Toolkit Legal and regulatory requirements relating to information handling will always be core to the national IG agenda. The Information Governance Toolkit provides a mechanism to allow organisations to measure and ensure compliance with these requirements through a process of annual assessment. The requirements include the: • Data Protection Act 1998. • Confidentiality NHS Code of Practice. • International Security Standard: ISO/IEC 27002:2005. • Information Security NHS Code of Practice. • Records Management NHS Code of Practice. • Freedom of Information Act 2000. The standards relating to each of the above initiatives also support and impact other performance and quality initiatives in the NHS, including ISO / IEC standards, the NHS Care Record Guarantee (CRG) and the IG Statement of Compliance. The Toolkit is therefore a key component of the IG Assurance Framework. It is a performance tool mandated by the Department of Health (DH), which requires NHS organisations, including Foundation Trusts, to complete and submit an annual return by 31 March each year. Each annual return is mandated by a Gateway number and Review of Central Returns reference number (ROCR). Year end assessment scores reported by organisations are used by the Healthcare Commission as a cross check for compliance with core standard C9 of Standards for Better Health. Version 6 of the IG Toolkit was released on 30 June 2008 and, as a direct result of the Cabinet Office review and Information Governance Assurance Programme discussed above, it included three new requirements; one relating to the establishment of the Senior Information Risk Owner role and two relating to Registration Authority responsibilities. Version 6 also introduced specific assessment sets for completion by NHS Business Partners/ Independent Treatment Centres/ Arms Length Bodies and developmental requirements for Dentists and Pharmacies. 26 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 28 Connecting for Health Digital Information Policy The Digital Information Policy team are responsible for maintenance and updating of the IG Toolkit, and providing assessment sets for new organisation-types as they are brought within the IG Assurance Framework. The NHS Connecting for Health IG Statement of Compliance NHS Connecting for Health (NHS CFH) is supporting the NHS to deliver better, safer care for patients by introducing new information technology systems and services which improve the way information is stored and shared in the NHS. The new information technology systems and services are together known as the National Programme for IT (NPfIT). NHS CFH is also responsible for existing business critical national NHS IT systems and legislative and digital policy advice on information systems for the NHS. All organisations wishing to access and use NHS CFH systems and services, including the N3 network, must meet the terms and conditions in the IG Statement of Compliance (IGSoC). The IGSoC is the agreement between NHS CFH and Approved Service Recipients that sets out the information governance policy and terms and conditions for use of NHS CFH services. The IGSoC contains a number of obligations which aim to preserve the integrity of these services. The IGSoC requires: • No patient identifiable data or other sensitive data is stored or processed offshore, where the location is deemed non-compliant with the NHS CFH Offshore Policy. • The right of audit by NHS CFH or nominated third parties. • Change Control Notification procedures and approvals processes. • Organisations to achieve, or be working towards, ISO27001. • Organisations to report security events and incidents. The IGSoC process is supported by annual completion of the IG Toolkit with a minimum of Level 2 performance against key requirements. The NHS Care Record Guarantee The NHS Care Record Guarantee sets out the rules that will govern information held in the NHS Care Records Service. It is reviewed at least every twelve months by the National Information Governance Board for Health and Social Care (NIGB). It was developed by the NIGB’s predecessor organisation, the Care Record Development Board (CRDB). The Guarantee covers: • people's access to their own records. • controls on others' access. • how access will be monitored and policed. • options people have to further limit access. • access in an emergency, and • the procedure when someone cannot make decisions for themselves. 27 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 29 Connecting for Health Digital Information Policy The Guarantee was first published in 2005 and revised in 2006 and 2007. The 2007 version of the Care Record Guarantee has emphasised and strengthened the clear commitment to the confidentiality and security of patient's information. There are several minor changes including the introduction of standardised terms to reduce ambiguity and improve clarity. The implementation of the 2005 Mental Capacity Act has been referred to, and there are several new sections regarding: • the Summary Care Record - introducing the summary care record and indicating that patients have the choice to not have one at all. • information for parents and young people - emphasising the importance of parents and healthcare professionals in supporting and encouraging children to make decisions for themselves. • an extra section that clearly outlines the processes involved in keeping patient electronic records secure and confidential, and • a 'how to complain section', which directs patients to their local PALs office if they feel the commitments of the Care Record Guarantee are not being upheld. IG Education, Training and Development The Information Governance Training Tool (IGTT) The IG Training Tool is an online tool focusing on all aspects of Information Governance (IG) learning. It has been designed by NHS Connecting for Health Digital Information Policy team in conjunction with Epic (e-learning design and development specialists). The aim of the tool is to develop and improve staff knowledge and skills regarding information governance, to support the provision of high-quality health & social care. The materials are available to any interested individuals through the ‘Guest tour’ view but if an organisation wishes to make full use of the user e-learning management and reporting tools they must be registered. In addition to the IG e-learning modules, the site includes a suite of introductory IG training materials that can be used as online training or as face to face classroom based training. The tool provides best practice guidelines to ensure confidential and secure processing of personal information. The aim of the tool is to improve IG standards through education and awareness. The IGTT enables NHS organisations to train all their staff in IG principles and to truly embed IG into an organisation. The initial release provides introductory materials relevant to all staff but over the next two years it will expand to provide a structured e-learning programme with Introductory, Foundation and Practitioner level modules. Introductory materials are aimed at all staff members. Foundation materials build on the introductory modules and are relevant to all those who process personal information routinely as part of their role; they will also be relevant for those with supervisory responsibilities. Practitioner materials will be primarily for those engaged in or intending to take on specialist IG roles. 28 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 30 Connecting for Health Digital Information Policy The IGTT is an excellent example of a successful deployment of IT in support of real business needs. For many years, NHS organisations have spent a lot of money on private training providers. The IGTT is free to NHS users and therefore allows organisations to redirect those resources. Furthermore, as it is a web-based resource there is no need to release several staff at once to attend face to face training. Staff can undertake the training at their own pace and have the opportunity to take an assessment and obtain a certificate on successful completion. Work is also underway on the development of an accredited certificate with the British Computer Society. Locum, contract and agency staff can easily be directed to undertake the training. The reporting function allows organisation administrators to monitor and review user training performance and progress. Further developments are being made to improve the user management and reporting functionality. Development and design of the tool The NHS has been making steady progress towards improving its information governance over the last few years. The HM Revenue and Customs loss of two discs containing personal data has, however, had a major impact, markedly raising the profile of IG and generating a need for assurances of IG processes. As set out in other areas of this delegate pack, David Nicholson, Chief Executive of the NHS, issued a series of letters containing specific actions that NHS organisations should take to provide IG assurances, including induction and training. The Digital Information Policy team was already developing the IGTT to support the existing IG Toolkit. The content of the tool has been driven by the training needs analyses carried out in 2007 for Caldicott Guardians and IG leads; and by the requirement for NHS organisations to provide IG assurances, including induction and mandatory IG training for their staff. The content of some of the modules within the tool has been reviewed by IG Leads and their feedback incorporated, additionally, introductory materials have been piloted in general practice and PCT workshops. Future developments Over the coming two to three years several improvements are planned for the IGTT, some of which have been proposed by users. Development of 40 hours worth of new e-learning modules: to include a combination of IG topic areas at Foundation and Practitioner level. Some materials currently under development and due for release in 2009 are: • Information risk management at Introductory and Foundation level. • The roles of the Senior Information Risk Owner and Information Asset Owners. • The role of the Caldicott Guardian in an NHS trust. • Dealing with consent and confidentiality issues. • A series of records management modules covering both corporate and health records. • Laying the foundations for good medical practice - medical record keeping. • Information security management and business continuity. 29 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 31 Connecting for Health Digital Information Policy Creation of a formally accredited qualification: this is being developed in conjunction with the British Computer Society (BCS). In time, staff will be able to use the IGTT as course material in preparation for the BCS computer centre based exam and obtain formal IG qualifications at Introductory, Foundation and Practitioner levels. The examination question bank and process will be piloted during the month of May 2009, with a view to launch the formal qualification soon after. New administration permissions: the first will allow Organisation Administrators to set up Support Administrators, who will have similar user rights and access. The second will allow Superusers to set up an IG training lead as the Organisation Administrator for more than one organisation, allowing the Administrator to manage and access reporting for more than one organisation. Widening the criteria for registered access: currently registration on the IGTT is restricted to those with NHS, Social Care or Government email addresses. Users who work on behalf of, or closely with, these organisations but do not have permitted email addresses can now apply for registration access through the IGTT helpdesk and, if appropriate, the team will arrange registration. Bulk uploads of users: this will allow Organisation Administrators to upload a CSV file of data to add all staff employed within their organisation onto IGTT. This will automatically register staff and hence give Administrators an holistic view of IG training engagement and progress. Reporting tool improvements: these will enable Organisation Administrators for SHAs and PCTs to run in-depth reports, for example: • SHA leads will be able to obtain summary and detailed reports for organisation and user engagement with the IGTT for all NHS Trusts and PCTs within the SHA region. • PCT leads will be able to obtain summary and detailed reports for Practice and user engagement with the IGTT for all Practices within the PCT area. • The Digital Information Policy team will have enhanced reporting tool on all organisations and users registered on the IGTT. New Department field: Organisation Administrators will be able to set up a drop down list of all departments or directorates they would like to report by. Once activated by the Administrator, all their staff will be able to select the appropriate department they work for upon registration or within ‘Your profile’ when logged in. This additional field was requested by Administrators to assist performance monitoring. 30 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 32 Connecting for Health Digital Information Policy Newsletter and prompting absent user functions: The newsletter tool will provide the Organisation Administrators with the ability to communicate via email to all the users registered under their Organisation’s National Administrative Code. The prompt function will be set by the DIP team for modules deemed to be mandatory/essential for users to complete. This means that the tool will automatically email users who have registered on the tool but not completed the module or passed the module assessment, within a certain period of time. Link with the Electronic Staff Record (ESR): work is underway to link the IGTT to ESR through the National Learning Management System. This is at very early stages of development and due to the complexity of the products concerned it will take some time until the migration or implementation of such relationship. 31 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 33 Connecting for Health Digital Information Policy Other IG qualifications - Foundation Degree There have been several major changes within the NHS all impacting on Information Governance (IG), particularly for SHAs and PCTs who have been assigned additional responsibilities following the Data Handling Review. These two organisation types are already the least mature in their IG capability and so are not well-prepared for extra responsibility. The IG resourcing project carried out by the Digital Information Policy team identified a skills shortage and recruitment and retention problems within the field of IG, particularly within these organisation-types. Recruiting an IG manager that can meet all requirements has proved to be extremely difficult in many areas of the country. One of the alternative approaches put forward is to assign an associate director level to oversee IG issues (perhaps one day a week) and develop a more junior person into the IG lead role. To facilitate the progression of staff from IG assistant or other junior informatics roles moving into IG officer roles, and the sideways movement of practitioner level staff from non-IG roles, it is proposed to create a Foundation Degree in Information Governance, which will be developed in accordance with the guidance contained within Skills for Health: Foundation Degree Framework for the Health Sector. The aims of the Foundation Degree in Information Governance are to: • Assist NHS organisations to begin to address the identified recruitment and retention difficulties. • Assist students to pursue or develop a career in IG by providing: • In depth knowledge of Information Governance principles and concepts. • Professional accreditation and a qualification in Information Governance. • A firm preparatory base for those students wishing to continue their studies to full degree level and beyond. The learning outcomes of the Foundation Degree in Information Governance will comprise three levels: • Core learning outcomes. • General learning outcomes. • Subject specific learning outcomes. An overview of each level is reproduced below. Core learning outcomes: overview These will be based on National Occupational Standards (NOS) and incorporate the core learning common to all foundation degrees. Recognising that students may come from a range of educational backgrounds, each student will have the opportunity to develop the following individual skills: • study skills – academic and work-based • personal and professional development planning/portfolio building • literacy, numeracy, communication 32 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 34 Connecting for Health Digital Information Policy • interpersonal skills and team-working • research and evidence appraisal skills Students will also be required to demonstrate that they have obtained IG skills in relation to: • health and social care context • service users rights, equality and diversity • codes of conduct, ethics and the law • user centred service • health and safety • risk assessment General learning outcomes: overview The Foundation Degree in Information Governance will have two types of general learning outcomes: • NHS Knowledge and Skills Framework Core dimensions - there are 6 core dimensions, relevant to every post in the NHS, which will be embedded at the below levels within the Foundation degree and clearly mapped: • C1 - Communication, Level 3: Develop and maintain communication with people about difficult matters and/or in difficult situations • C2 - Personal and people development, Level 3: Develop oneself and contribute to the development of others • C3 - Health, safety and security, Level 3: Promote, monitor and maintain best practice in health, safety and security • C4 - Service improvement, Level 2: Contribute to the improvement of services • C5 - Quality, Level 3: Contribute to improving quality • C6 - Equality and diversity, Level 2: Support equality and value diversity. • Quality Assurance Agency for Higher Education (QAA) level descriptors - the Foundation degree is an intermediate qualification within the QAA Framework for Higher Education Qualifications. This requires that students will have developed a sound understanding of the principles in their field of study, and will have learned to apply those principles more widely. Through this, they will have learned to evaluate the appropriateness of different approaches to solving problems. Their studies will have a vocational orientation, enabling them to perform effectively in their chosen field. They will have the qualities necessary for employment in situations requiring the exercise of personal responsibility and decision-making. The detailed QAA descriptors will be taken into account during the design and delivery of the Foundation degree, see: www.qaa.ac.uk/academicinfrastructure/fheq/ewni08/#p4.2 33 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 35 Connecting for Health Digital Information Policy Subject specific learning outcomes Subject specific learning outcomes will be drawn from a number of areas: • QAA subject benchmarks - the health and social care benchmark statements available are not relevant to the field of IG. Additionally, there are no intermediate (i.e. Foundation degree) level statements; therefore consideration will be given to drawing information from the benchmark statements for “librarianship and information management” and tailoring it to an intermediate level course. See: www.qaa.ac.uk/academicinfrastructure/benchmark/statements/ Librarianship07.asp • Health Informatics Career Framework - the Framework contains the job roles of Information Governance Officer set at career framework level 6 and Information Governance Assistant set at career framework level 4. It is intended that students will achieve competences, skills and qualifications somewhere between these two levels once they have completed the Foundation Degree. This will provide a progressive and achievable route for staff already working at level 4 whether within or outside of IG roles. Therefore, initial work has commenced on the development of a new job role (i.e. junior Information Governance Officer) with linked competences etc at career framework level 5. As with existing HICF job roles, the new job role will include National Occupational Standards linked to KSF dimensions (in addition to those set out under general learning outcomes), which will be used to form subject specific learning outcomes. Current job roles are available on the Health Informatics Career Framework website at: www.hicf.org.uk/ and relevant National Occupational Standards are at: http://www.hinos.org.uk/ • The IG Toolkit - the course forms part of the IG Training Strategy for the NHS and therefore it will be closely aligned to the standards within the NHS Connecting for Health IG Toolkit. See: www.igt.connectingforhealth.nhs.uk • Professional standards - learning outcomes will also be drawn from the United Kingdom Council for Health Informatics Professions (UKCHIP) level 2. See: www.ukchip.org.uk Level 2 is for people who are establishing their career in HI and have a significant degree of autonomy in their post. A minimum of 2 years experience and a qualification of at least NQ level 3 (e.g. A levels or first degree) is required. At the most basic level, on completion of the course; a student should be able to: • Understand and explain each of the component parts of Information Governance including how to: • Set up and maintain an IG framework. • Ensure compliance with the legal aspects of IG. • Improve and maintain good records management within their organisation. 34 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 36 Connecting for Health Digital Information Policy • Evidence how to resolve and reduce the occurrence of confidentiality and security incidents. • Demonstrate an awareness of current issues affecting IG, e.g. the systems and services being delivered by the National Programme for IT. • Demonstrate an ability to address through relevant implementation an improvement to existing IG practice within their organisation. Anyone interested in assisting the development of the Foundation Degree in Information Governance should contact the project lead at: [email protected] Experiences on the IG Masters course - Qualifications in Healthcare Information Governance (HIG) The University of Bath School for Health introduced a range of qualifications in HIG in 2006. At the time this was the only post-graduate course in the UK specifically about information governance for healthcare professionals. The programme was developed by the university with The Royal College of Surgeons of Edinburgh, and offered PG Certificate, PG Diploma, and MSc qualifications, of one, two and three years duration respectively. The first students started in October 2006, and I enrolled with the first cohort; most of whom were from Scotland. I am now in the third, research project, year. Having submitted my CV and application form in a moment of bravado I was delighted, but also a little frightened, to be accepted. As something of a technophobe, my worst fear was having to use MOODLE (the university’s virtual learning environment - VLE), this is an interactive website with a number of features and activities designed to “engage learners and promote collaborative studentcentred learning”. Within a few weeks I was attending a face-to-face induction day in Edinburgh at the Royal College of Surgeons. This was a great day: I’ve always loved Edinburgh, and meeting the other participants in such prestigious surroundings was an amazing bonus. The first unit covered Confidentiality and Data Protection in the NHS, within the context of the wider UK and EU legislation, and the next; Freedom of Information and Records Management, a really useful module. The last Unit of the first year was Information Security surrounding the EPR. In the second year we tackled Clinical Systems, in two parts. The first was learning about system development methods. At the time these seemed very difficult and it wasn’t until later that I understood and appreciated why they were part of the course. Because system development is a large part of Information Management, and destined to be a much greater part, understanding how systems are developed, and being able to see why they may not work as well as they could, is a key skill for anyone using them. It also enables IT and IG people to talk to one another in the same language – as a result I feel much better able to get IG principles incorporated into IT. 35 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 37 Connecting for Health Digital Information Policy The course has also included several “residentials” at Edinburgh and Bath, and at these we have had lectures from various professionals on subjects as diverse as: Communication; leadership and the organisation of change; IT security and governance, and Knowledge and Information Management. My chosen Diploma-level (second year) units covered leadership and the management of organisational change. These are topical and divergent, especially in workplaces like public authorities which are notoriously resistant to change. I found the distinction between leadership and management a very interesting exercise. The HIG-in-practice portfolio part of the course, running alongside the other units, involved various milestone exercises in the workplace, including shadowing a member of staff in a different work area, to identify the present and potential impacts of the requirements of the Information Governance Assurance Framework. I thought I knew all about information flows, having worked in Medical Records, Coding and Data Quality before accepting the HIG lead role, but the extent to which HIG principles permeate every part of the hospital still came as something of a surprise. For the dissertation year, all the third year MSc students at the Bath University School for Health came together for lectures and advice on their choice of subject and guidance about getting started. Much of the early effort is writing a protocol for the dissertation and getting that accepted by the University as suitable as a Master’s level project. I found meeting doctors (medical ones) and Health Informatics students very interesting, and was reassured that we all shared many of the same concerns and anxieties. If anyone is contemplating embarking on this or a similar course of study they should be sure they have the time and support from their employers for the considerable commitment necessary. I have not yet completed the course, but have already found what I have learned beneficial in my current job, though it has been, I must admit, extremely hard work. For further details of entry requirements, the current syllabus, etc., and to apply, contact the University at www.bath.ac.uk/health/programmes/hig Jill Stretton Healthcare Information Governance Manager Shrewsbury and Telford Hospital NHS Trust 36 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 38 Connecting for Health Digital Information Policy Information sharing Richard Thomas and Mark Walport: Data sharing review On 25 October 2007 the Prime Minister asked Dr Mark Walport of the Wellcome Trust and the Information Commissioner, Richard Thomas, to independently review the framework for the use of personal information in the public and private sectors. The terms of reference of the review were to: • consider whether there should be any changes to the way the Data Protection Act 1998 operates in the UK and the options for implementing any such changes. • provide recommendations on the powers and sanctions available to the regulator and courts in the legislation governing data sharing and data protection. • provide recommendations on how data-sharing policy should be developed in a way that ensures proper transparency, scrutiny and accountability. The review's final report concluded that: • there is a lack of transparency and accountability in the way organisations deal with personal information. • there is confusion surrounding the Data Protection Act, particularly the way it interacts with other strands of law. • greater use could be made of the ability to share personal data safely, particularly in the field of research and statistical analysis. • the Information Commissioner needs more effective powers, and the resources to allow him to use them properly. The report made a series of recommendations aimed at transforming the personal and organisational culture of those who collect, manage and share information. The recommendations are grouped under the headings of developing culture, the legal framework, the regulatory body, research and statistical analysis, and safeguarding and protecting publicly available information: Developing culture • Recommendation 1: All organisations handling or sharing significant amounts of personal information should clarify in their corporate governance arrangements where ownership and accountability lie for the handling of personal information. • Recommendation 2: Companies should review at least annually their systems of internal controls over using and sharing personal information; and they should report to shareholders that they have done so. 37 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 39 Connecting for Health Digital Information Policy • Recommendation 3: Organisations should take the following good-practice steps to increase transparency: • Fair Processing Notices should be much more prominent in organisations’ literature, both printed and online, and be written in plain English. The term ‘Fair Processing Notice’ is itself obscure and unhelpful, and we recommend that it is changed to ‘Privacy Policy’. • Privacy Policies should state what personal information organisations hold, why they hold it, how they use it, who can access it, with whom they share it, and for how long they retain it. • Public bodies should publish and maintain details of their data-sharing practices and schemes, and should record their commitment to do this within the publication schemes that they are required to publish under the Freedom of Information Act. • Organisations should publish and regularly update a list of those organisations with which they share, exchange, or to which they sell, personal information, including selected third parties. • Organisations should use clear language when asking people to opt in or out of agreements to share their personal information by ticking boxes on forms. • Organisations should do all they can (including making better use of technology) to enable people to inspect, correct and update their own information – whether online or otherwise. • Recommendation 4: All organisations routinely using and sharing personal information should review and enhance the training that they give to their staff on how they should handle such information. • Recommendation 5: Organisations should wherever possible use authenticating credentials as a means of providing services and in doing so avoid collecting unnecessary personal information. The legal framework • Recommendation 6: Any changes to the EU Directive will eventually require changes to the UK’s Data Protection Act. We recognise that this may still be some years away, but we nonetheless recommend strongly that the Government participates actively and constructively in current and prospective European Directive reviews, and assumes a leadership role in promoting reform of European data law. • Recommendation 7(a): New primary legislation should place a statutory duty on the Information Commissioner to publish (after consultation) and periodically update a data-sharing code of practice. This should set the benchmark for guidance standards. 38 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 40 Connecting for Health Digital Information Policy • Recommendation 7(b): The new legislation should also provide for the Commissioner to endorse context-specific guidance that elaborates the general code in a consistent way. • Recommendation 8(a): Where there is a genuine case for removing or modifying an existing legal barrier to data sharing, a new statutory fast-track procedure should be created. Primary legislation should provide the Secretary of State, in precisely defined circumstances, with a power by Order, subject to the affirmative resolution procedure in both Houses, to remove or modify any legal barrier to data sharing by: • repealing or amending other primary legislation; • changing any other rule of law (for example, the application of the common law of confidentiality to defined circumstances); or • creating a new power to share information where that power is currently absent. • Recommendation 8(b): Before the Secretary of State lays any draft Order before each House of Parliament, it should be necessary to obtain an opinion from the Information Commissioner as to the compatibility of the proposed sharing arrangement with data protection requirements. The regulatory body • Recommendation 9: The regulations under section 55A of the Data Protection Act setting out the maximum level of penalties should mirror the existing sanctions available to the Financial Services Authority, setting high, but proportionate, maxima related to turnover. • Recommendation 10: The Government should bring the new fine provisions fully into force within six months of Royal Assent of the Criminal Justice & Immigration Act, that is, by 8 November 2008. • Recommendation 11: Organisations should notify the Information Commissioner when a significant data breach occurs. We do not propose this as a mandatory requirement, but in cases involving the likelihood of substantial damage or distress, we recommend the Commissioner should take into account any failure to notify when deciding what, if any, penalties to set for a data breach. • Recommendation 12: The Information Commissioner should have a statutory power to gain entry to relevant premises to carry out an inspection, with a corresponding duty on the organisation to co-operate and supply any necessary information. Where entry or co-operation is refused, the Commissioner should be required to seek a court order. 39 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 41 Connecting for Health Digital Information Policy • Recommendation 13: Changes should be made to the notification fee through the introduction of a multi-tiered system to ensure that the regulator receives a significantly higher level of funding to carry out his statutory dataprotection duties. • Recommendation 14: The regulatory body should be re-constituted as a multimember Information Commission, to reinforce its status as a corporate body. Research and statistical analysis • Recommendation 15: ‘Safe havens’ should be developed as an environment for population-based research and statistical analysis in which the risk of identifying individuals is minimised; and furthermore we recommend that a system of approving or accrediting researchers who meet the relevant criteria to work within those safe havens is established. We think that implementation of this recommendation will require legislation, following the precedent of the Statistics and Registration Service Act 2007. This will ensure that researchers working in ‘safe havens’ are bound by a strict code, preventing disclosure of any personally identifying information, and providing criminal sanctions in case of breach of confidentiality. • Recommendation 16: Government departments and others wishing to develop, share and hold datasets for research and statistical purposes should work with academic and other partners to set up safe havens. • Recommendation 17: The NHS should develop a system to allow approved researchers to work with healthcare providers to identify potential patients, who may then be approached to take part in clinical studies for which consent is needed. Safeguarding and protecting publicly available information • Recommendation 18: The Government should commission a specific enquiry into on-line services that aggregate personal information, considering their scope, their implications and their regulation. • Recommendation 19: The Government should remove the provision allowing the sale of the edited electoral register. The edited register would therefore no longer serve any purpose and so should be abolished. This would not affect the sale of the full register to political parties or to credit reference agencies. 40 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 42 Connecting for Health Digital Information Policy Ministry of Justice: Response to data sharing review The response recognised that several of the recommendations within the Thomas/Walport report complemented the recommendations of the Cabinet Office data handling review (DHR). The report committed Government to implementing the key recommendations of both reviews to improve data management. The report provided a response to each of the recommendations, a summary of which follows: • Recommendation 1: corporate governance arrangements and • Recommendation 2: annual review of internal controls It was highlighted that Government departments had made significant progress implementing the requirements of the DHR. In particular, in relation to: • Publication of information regarding data losses; • Appointment of Senior Information Risk Owners (SIROs) and • Ensuring that those in their delivery chain, including public and private sector organisations, are aware of their responsibilities in relation to the new data handling measures. • Recommendation 3: good-practice steps to increase transparency The response agreed with the main thrust of the recommendations but felt it was for the organisations to determine the most appropriate terminology for their business area in relation to fair processing notices. • Recommendation 4: review and enhance training given to staff on handling information Training and awareness of good data security practice within Government departments was discussed in the DHR. All Government departments are already addressing core measures to provide data security training for all staff accessing protected personal data. • Recommendation 5: use authenticating credentials to provide services and avoid collecting unnecessary personal information Several authentication services were outlined with the Employee Authentication Service (EAS) singled out as showing Government commitment to such services. Initiatives that will streamline services and avoid unnecessary collection of personal information include ‘Tell Us Once’, which looks at the feasibility of a service where citizens can report a birth, death or change of address to Government, only once ensuring Government responds in a co-ordinated manner. • Recommendation 6: the Government should actively participate in reviews of the European Directive and promoting reform of European data law The Government has committed to working to ensure that UK and European law remains properly equipped to deal with challenges brought by technological and social change. 41 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 43 Connecting for Health Digital Information Policy • Recommendation 7(a): a duty on the IC to publish a data-sharing code of practice The ICO will be asked to draft a code which will: • provide practical guidance to the public, particularly data controllers and data processors, about how to share personal data in accordance with the requirements of the DPA; and • promote good practice in the sharing of personal data A breach of, or compliance with, the Code will be taken into account by the courts, the Information Tribunal and the ICO whenever it is relevant to a question arising in legal or enforcement proceedings • Recommendation 7(b): a provision for the IC to endorse context-specific guidance that elaborates the general code Where sector-specific guidance is required, the ICO should consult with business and those organisations that represent business in that sector to ensure the guidance is as useful and relevant as possible. • Recommendation 8(a): fast-track procedure for removing or modifying an existing legal barrier to data sharing Government will legislate to create a gateway for data sharing powers, which will be subject to the Parliamentary Affirmative Resolution procedure. This will create a more streamlined process, retaining the element of parliamentary scrutiny to ensure transparency in data sharing policy and ensuring such power is proportionate. We intend to bring forward legislation to confer upon the Secretary of State a power to permit or require the sharing of personal information between particular persons or bodies, so long as a robust case can be made to use that power. The power will also be used to simplify the data protection framework and remove any unnecessary obstacles to data sharing. • Recommendation 8(b): Government to obtain opinion from the IC as to the compatibility of any proposed sharing arrangements with data protection requirements The ICO should provide independent oversight of proposals being taken forward via this process. • Recommendation 9: mirror the existing sanctions available to the Financial Services Authority The implementation of a model similar to that operated by the Financial Services Authority is under consideration. • Recommendation 10: bring the new fine provisions fully into force It was hoped to bring the new fine provisions into force shortly. 42 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 44 Connecting for Health Digital Information Policy • Recommendation 11: notification of significant data breaches to the IC Following the publication of the DHR it is mandatory for Government departments to share details of significant actual or potential losses of personal data with the ICO. A mandate will be given to the ICO to publish guidance for organisations on when to notify breaches of the data protection principles. • Recommendation 12: statutory power for IC to gain entry to relevant premises The response to this recommendation is outlined in the package of measures set out in the response to the Ministry of Justice consultation on the Information Commissioner’s inspection powers and funding arrangements under the Data Protection Act 1998. See Appendix B. • Recommendation 13: make changes to the notification fee The response to this recommendation is outlined in the package of measures set out in the response to the Ministry of Justice consultation on the Information Commissioner’s inspection powers and funding arrangements under the Data Protection Act 1998. See Appendix B • Recommendation 14: re-constitute the Information Commission Further work will be undertaken to consider the case for reconstituting the Office of the Information Commissioner. • Recommendation 15 and 16: development of safe havens Through the Research Capability Programme, established via the NHS Connecting for Health in 2007 programme, the Department of Health is working with the Information Centre for Health and Social Care to develop safe havens. They will be designed to enable appropriate processing for health research purposes of patient information and other data derived from patient information. • Recommendation 17: allow approved researchers to work with healthcare providers to identify potential patients The Department of Health will develop a system to allow approved researchers to work with healthcare providers for this purpose, under a duty of confidentiality equivalent to the duty owed by health professionals. The Department will develop mechanisms to help healthcare providers operate the system consistently, and will ensure they work with the employers of the approved staff to deal effectively with any breaches of confidentiality. The independent National Information Governance Board will monitor the operation of the system. • Recommendation 18: a specific enquiry into on-line services that aggregate personal information This recommendation was said to merit further consideration. • Recommendation 19: remove the provision allowing the sale of the edited electoral register A public consultation will be held on this recommendation. 43 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 45 Connecting for Health Digital Information Policy Case studies: the UK Council of Caldicott Guardians These case studies are from queries raised by the wider Caldicott community and discussed by the UK Council of Caldicott Guardians. The responses expressed do not constitute legal advice; they are the considered opinion of the Council. If you require legal advice you should consult your organisation’s legal advisors. The Council welcome any queries that promote similar discussion, so please see this as your opportunity to raise issues, obtain a response and assist the Council to build up a body of frequently asked questions and answers and develop expertise across the community. Queries should be sent to: [email protected] Proactive disclosure of information to the police A day surgery unit are reviewing their policy on discharge. They give advice to patients beforehand that they should not drive after having a general anaesthetic. Occasionally, the patient is recovered and then wishes to drive themselves. The unit is proposing to provide the following statement to these patients: "We will inform the police if you state that you intend to drive yourself home after recovering from a general anaesthetic". Would this disclosure be classified as satisfying the "robust public interest justification"? Considerations In reaching its decision the Council considered: • The common law duty of confidence. • The length of time that impairment of driving ability is likely to last in a person recovering from day case surgery under general anaesthetic. Confidentiality considerations The Confidentiality NHS Code of Practice and the General Medical Council guidance: "Confidentiality: Protecting and Providing Information” set out the circumstances under which a disclosure of confidential information without consent is permitted if it is in the substantial public interest to disclose. The discloser must decide whether the public good that would be achieved by the disclosure outweighs both the obligation of confidentiality to the individual patient concerned and the broader public interest in the provision of a confidential service. One example of where disclosure of personal information without consent may be justified in the public interest is where failure to disclose may expose the patient or others to risk of death or serious harm. Clinicians also have a duty of care to people other than the patient, i.e. there are times when the safety of others must take precedence. If the discloser is of the view that disclosure is necessary to protect a third party from death or serious harm, the information should be promptly reported to an appropriate person or authority. 44 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 46 Connecting for Health Digital Information Policy Anaesthetic considerations Before disclosing, staff must consider how long the impairment of driving ability lasts in a person recovering from day case surgery under general anaesthetic. According to the Royal College of Anaesthetists impairment will vary (generally lasting between 24 to 48 hours) depending on the type of surgery; the length of time the patient is anaesthetised; and other patient-specific factors. However, it is accepted practice that patients must be informed that they should not drive on the same day that they have received a general anaesthetic. Patients should also be aware that their insurance is likely to be invalid if they do so. The Council’s decision If a circumstance arises where a patient insists on driving despite there being clear evidence that he/she is likely to be a danger and to pose a significant "risk of death or harm" to themselves or to others then, in the Council’s view, there is a public interest duty of disclosure which over-rides the duty of confidentiality. The disclosure should be made in line with the Confidentiality NHS Code and the GMC's guidance listed above. The Council also suggested the following text would be more appropriate: “We will inform the police if we believe you are still significantly affected by general anaesthetic and you ignore our advice not to drive.” Retention of investigation information relating to staff The query was made following the enactment of the new legislation for the safe use and management of controlled drugs. An Accountable Officer has responsibility for ensuring that appropriate systems are in place for reporting suspected criminal activity involving controlled drugs to the police. Whilst developing a written protocol to meet this requirement, there was uncertainty about what should be done with investigation information collected in relation to the following scenarios: • When a concern or suspicion is raised about a member of staff but the person reporting the concern has no supporting physical evidence. • When a concern or suspicion results in a police investigation into an individual’s actions but the individual is not charged. • When an individual is charged by the police but is not convicted. The scenarios raised several queries, including: • Should the information be retained if the individual is not convicted? • If the information is retained how long should it be kept? • What are the implications if the information is destroyed and subsequent concerns or suspicion are raised about the same individual resulting in a conviction? 45 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 47 Connecting for Health Digital Information Policy Considerations In reaching its decision the Council considered: • Whether the information should be retained at all. • If it was retained, that there should be a short retention period. • Accessibility - i.e. who is able to gain access to the information etc. Decision Integral to the retention of information is that it is held in accordance with the organisation’s overall information governance policy with due consideration for security and confidentiality. The information gathered is extremely sensitive and requires robust access controls so that only those with a genuine need to know the information are able to access it. Although all the scenarios relate to unsubstantiated or unproven allegations, organisations need to be aware that such information could later add up and identify provable criminal activity. Additionally, organisations should make sure that individuals are aware of their rights under Data Protection Act, and that redacted or complete information might have to be supplied about an allegation. 1. When a concern or suspicion is raised about a member of staff but the person reporting the concern has no supporting physical evidence: It is important to take into account that an unsubstantiated 'concern' could be malicious. However, the concern will still need to be investigated and it would be appropriate to hold a summary referring to any investigation carried out and the fact that there was no evidence to support the allegation. 2. When a concern or suspicion results in an investigation into an individual’s actions but the individual is not charged: Information about the investigation, the evidence gathered and referral to the police should be retained. It should be held as part of that person's record even if they were exonerated. 3. When an individual is charged but is not convicted: Information about the investigation, the evidence gathered and referral to the police should be retained. It should be held as part of that person's record even though they have not been convicted. 46 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 48 Connecting for Health Digital Information Policy Links and contacts Departments and Bodies Association of Directors of Adult Social Services http://www.adss.org.uk/ Department of Health http://www.dh.gov.uk/ Information Commissioner’s Office http://www.ico.gov.uk/ National Information Governance Board for Health and Social Care http://www.nigb.nhs.uk/ NIGB: Ethics and Confidentiality Committee http://www.nigb.nhs.uk/ecc NHS Connecting for Health http://www.connectingforhealth.nhs.uk/ UK Council of Caldicott Guardians http://www.connectingforhealth.nhs.uk/systemsandservices/infogov/caldicott Products and Services Department of Health: Information Policy http://www.dh.gov.uk/en/Managingyourorganisation/Informationpolicy/index.htm Information Governance http://www.connectingforhealth.nhs.uk/systemsandservices/infogov IG Toolkit https://www.igt.connectingforhealth.nhs.uk/ IG Training Tool http://www.igte-learning.connectingforhealth.nhs.uk/igte/index.cfm IG Statement of Compliance http://www.connectingforhealth.nhs.uk/systemsandservices/infogov/igsoc 47 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 49 Connecting for Health Digital Information Policy Ministry of Justice: Data sharing and protection http://www.justice.gov.uk/guidance/datasharing.htm NHS CFH: Information Security http://www.connectingforhealth.nhs.uk/systemsandservices/infogov/security NHS CFH: Infrastructure Security (N3 connection required) http://nww.connectingforhealth.nhs.uk/infrasec The NHS Records Management Roadmap http://www.connectingforhealth.nhs.uk/systemsandservices/infogov/records Publications Caldicott Guardian Manual 2006 http://www.connectingforhealth.nhs.uk/systemsandservices/infogov/caldicott/caldre sources/guidance Confidentiality: NHS Code of Practice http://www.dh.gov.uk/en/Managingyourorganisation/Informationpolicy/Patientconf identialityandcaldicottguardians/DH_4100550 Information Security Management: NHS Code of Practice http://www.dh.gov.uk/en/Managingyourorganisation/Informationpolicy/Information security/index.htm NHS Care Record Guarantee http://www.nigb.nhs.uk/guarantee NHS information governance: Guidance on legal and professional obligations http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAn dGuidance/DH_079616 NIGB Annual Report 2008 http://www.nigb.nhs.uk/about/publications/NIGB_Annual_Report_2008.pdf Records Management: NHS Code of Practice http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAn dGuidance/DH_4131747 48 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 50 Connecting for Health Digital Information Policy Helpdesk contacts The Department of Health and NHS Connecting for Health - Digital Information Policy Team helpdesk services: • IG Toolkit Helpdesk – [email protected] • IG Training Tool – [email protected] • Records Management – [email protected] • Information security – [email protected] Department of Health: Contact page: http://www.dh.gov.uk/en/ContactUs/index.htm UK Council of Caldicott Guardians [email protected] General Medical Council: Standards & Ethics enquiries • Tel: 020 7189 5404 • Fax: 020 7189 5401 • Email: [email protected] • Web: http://www.gmc-uk.org/about/contacts/ Nursing and Midwifery Council: Standards • Tel: 020 7333 6547 • Email: [email protected]/Individual contact details • Web: http://www.nmc-uk.org/aArticle.aspx?ArticleID=1587 Medical Defence Union: Medico/dento-legal queries and claims • 24-hour freephone: UK medical 0800 716 646; UK dental 0800 374 626; Ireland 1800 535 935 • Fax: 020 7902 5900 • Email: [email protected] • Web: http://www.the-mdu.com/topnav_contact_us_0/index.asp Information Commissioner’s Office: Contact page https://www.ico.gov.uk/Global/contact_us.aspx 49 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 51 50 63658 NHS Digital Policy - 1-53 5/2/09 11:28 Page 52 Connecting for Health Digital Information Policy Appendices Appendix A: The UK Council of Caldicott Guardians Appendix B: The National Information Governance agenda Appendix C: The NHS Information Governance Assurance Framework Appendix D: Information Sharing 51