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TechnologyForumDigitalHealthStåhlberg071015
Finnish opportunities in digital health technology and regulatory restrictions 7.10.2015 Director, Regulatory Affairs and compliance Tom Ståhlberg FiHTA Finnish digital health technology Terveysteknologia Suomessa – syntymästä kuolemaan Entäs softa? Copywright Tom Ståhlberg Finnish opportunities in digital health technology and regulatory restrictions When is a software a medical device? What is the implication? Can we live up to the demands? Mobile apps as an example Safety, safety, safety… Copywright Tom Ståhlberg Medical device or not? Medical device specific laws in about 100 countries What about the other (about) 300 countries? Wild West? Pharmaceutical law (MD = “drug” or quasi-drug) Custom-related laws and product liability laws Copywright Tom Ståhlberg European Union Medical Device Directives Active Implantable Medical Devices, AIMD (90/385/EC) Medical Devices, MDD (93/42/EC) In Vitro Diagnostic Medical Devices, IVD (98/79/EC Software included from the beginning! The amended Medical Device Directive, MDD 2007/47/EC transposed to the Finnish Suomen Laki Terveydenhuollon laitteista ja tarvikkeista (629/2010) Software stronger emphasis! Intended Use ”Intended by” the manufacturer is the key to if it is a medical device or not! Copyright Tom Ståhlberg Lääkinnällinen laite (Medical device): määritelmä Instrumentti, laitteisto, väline, materiaali tai muu yksinään tai yhdistelmänä käytettävä laite tai tarvike sekä sen asianmukaiseen toimintaan tarvittava ohjelmisto, jonka sen valmistaja on tarkoittanut käytettäväksi ihmisen a) sairauden diagnosointiin, ehkäisyyn, tarkkailuun, hoitoon tai lievitykseen, b) vamman tai vajavuuden diagnosointiin, tarkkailuun, hoitoon, lievitykseen tai kompensointiin, c) anatomian tai fysiologisen toiminnon tutkimiseen, korvaamiseen tai muunteluun; tai d) hedelmöitymisen säätelyyn, Copywright Tom Ståhlberg Lääkinnällinen laite (Medical device): määritelmä ….. ja joiden pääasiallista vaikutusta ihmiskehossa tai ihmiskehoon ei saavuteta farmakologisin, immunologisin tai metabolisin keinoin, mutta joiden vaikutusta voidaan tällaisilla keinoilla edistää. This applies also for software and digital health! Copywright Tom Ståhlberg Software as an MD the key = MD definition ”When the intended use is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man” Finnish opportunities in digital health technology and regulatory restrictions When is a software a medical device? What is the implication? Can we live up to the demands? Mobile apps as an example Safety, safety, safety… Copywright Tom Ståhlberg Right from the beginning Innovation not enough! Before product development: marketing and regulatory strategy! Take regulatory requirements into account from Day 1: Product specific requirements Quality Management System requirements 2. Which regulations apply? 1. Intended use 6. Declaration of conformity and CE marking 4. Essential requirements 3. Define risk class 5. Conformity assessment 7. Product registration Copywright Tom Ståhlberg 8. Throughout the product life cycle Product registration requirements: From Day 1! www.reguloiko.fi Finnish opportunities in digital health technology and regulatory restrictions When is a software a medical device? What is the implication? Can we live up to the demands? Mobile apps as an example Safety, safety, safety… Copywright Tom Ståhlberg Finnish Health Technology 2014 Export 1 800 milj. € Growth 8.3 % Regulations – from a trade barrier to a competitive edge! What about software business? Remember: embedded software included in almost all MDs! Standalone? Not yet too much, but great potential! Suomessa paljon mahdollisuuksia... 1. Electro-diagnostic devices GE Healthcare Oy 5. Medical aids Respecta Oy 2. X-ray and radiology Planmed Oy 6. In vitro-diagnostic equipment, systems, and reagents PerkinElmer Wallac Oy 3. Medical furniture Lojer Oy 4. Surgical, dental and other therapeutic instruments Planmeca Oy 7. eHealth, healthcare ICT 8. Health promotion and consumer products Mawell Oy HUR Oy FiHTA member companies Acute Oy Aidertech Oy Ani Biotech Oy Bioretec Oy BoneIndex Oy Clinius Oy ClothingPlus Oy Conforman Oy CorusFit Oy Delfin Technologies Oy Desigence Oy Diter-Elektroniikka Oy Ab Elekta Oy Emicaid Oy Emfit Oy Espotel Oy Etteplan Oy Finnmedi Oy Franke Medical Oy GE Healthcare Oy Healthy Life Devices Oy Horizon Wellness Oy HUR Oy Innokas Medical Oy Kojair Tech Oy Lewel Group Finland Oy Lojer Oy Mariachi Oy Mawell Oy Medfiles Oy Medikro Oy Medix Biochemica Oy Ab Mega Elektroniikka Oy Mendor Oy Merivaara Oy Mylab Oy Nemko Oy Nexstim Oy Optomed Oy Orion Diagnostica Oy Oulu Wellness Institute PerkinElmer Oy (Wallac) Philips Medical Systems Planmeca Oy Relaxbirth Oy RemoteA Oy Sartorius Biohit Liquid Handling Oy SGS Fimko Oy Sondi Oy Spark Ergonomics Oy Stick Tech Oy Sysdrone Oy TeleChemistry Oy Thermo Fisher Scientific Oy VTT Expert Services Suomen mahdollisuudet? Erinomainen kilpailukyky Maailman paras ICT-maa kilpailukyky Patentit 1. Sija 3. sija 9. sija Singapore, Ruotsi, Hollanti, Norja, Sveitsi, Meitä ennen: Korea, Japani, Kiina, Sveitsi, Saksa, USA, Tanska. Ruotsi 10. sija UK, Tanska, USA, Taiwan Copywright Tom Ståhlberg The future is behind the corner! Almost like science fiction • Visualization brain stimulation for guiding devices • Patient data portals • Finnish BlindSquare software • 3D-printing • Health games • Remote diagnostics and surgery • Health tourism • Mobile health apps • TYKS: ear diagnosis trial Copywright Tom Ståhlberg Finnish opportunities in digital health technology and regulatory restrictions When is a software a medical device? What is the implication? Can we live up to the demands? Mobile apps as an example Safety, safety, safety… Copywright Tom Ståhlberg Mobile (Medical) Apps Mobile apps – software applications running on a mobile platform (handheld, commercial off-the-shelf computing platform such as smart phones, tablets or other portable computers, with or without wireless connectivity)(or accessories attached to such) or a web-based software application tailored to a mobile platform but run on a server > 100 000 US FDA Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff US FDA focus Focus its regulatory oversight on a subset of mobile medical apps with greater risk to patients The majority are thus not to be subject for enforced requirements under the Federal Drug and Cosmetic Act (enforcement discretion) no manufacturer licensing, no product filing however, if goes wrong... however, strong recommendations to have QMS according to QSR When do regulations apply? Mobile apps used for facilitating health and wellness but which are not medical devices NOT a MD regulatory issue! When do regulations apply? Mobile Medical Applications, but low risk US FDA Enforcement discretion Mobile apps used for facilitating health and wellness but which are not medical devices NOT a MD regulatory issue! When do regulations apply? Mobile Medical Applications, high risk same regulations as for any medical device Mobile Medical Applications, but low risk US FDA Enforcement discretion Mobile apps used for facilitating health and wellness but which are not medical devices NOT a MD regulatory issue! ”Tailored approach supports innovation while protecting consumer safety” How can you know? Separate lists: Examples the FDA has cleared or approved Examples for which the FDA will exercise enforcement discretion In the Guidance: Examples that are not medical devices Examples enforcement discretion Examples FDA regulatory oversight focus If in doubt: US FDA web Division of Small Manufacturers, International and Consumer Assistance 513(g) process: provides confidential written response within 60 days (user fee, cover letter, apps description, description of use, proposed labeling of the apps and possible similar legally marketed device) SW and US FDA what else? Level of concern Data protection HIPAA GAMP Radio-frequency wireless technology in MDs Cybersecurity in MDs Finnish opportunities in digital health technology and regulatory restrictions When is a software a medical device? What is the implication? Can we live up to the demands? Mobile apps as an example Safety, safety, safety… Copywright Tom Ståhlberg Medical errors are quite common 250,000 deaths per year are caused by medical errors, making this the third-largest cause of death in the U.S., following heart disease and cancer Dr. Barbara Starfield, Johns Hopkins School of Hygiene and Public Health Fortunately, only a few related to MDs! Copywright Tom Ståhlberg Products and services must be safe and effective Copywright Tom Ståhlberg Easy regulations not possible Sääntelyn sujuvoittaminen? Copywright Tom Ståhlberg Regulations Not necessary to make the regulations less stringent But: predictability and stability obligatory Copywright Tom Ståhlberg
