mhealth software development

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  • 1.M H E A LT H S O F T WA R E D E V E L O P M E N T I A N D A R W I N , C E N T R E F O R G L O B A L E H E A LT H I N N O VA T I O N , U N I V E R S I T Y H E A LT H N E T W O R K , T O R O N T O

2. P L A N Software Development? Mobile? Medical? 3. S O F T WA R E D E V E L O P M E N T: T H E L I N G O 1 4. Software is written by developers in programming languages Just as poets & writers use natural languages There are hundreds to choose from Many ways to categorize programming languages! by level, by orientation, by purpose, 5. L E V E L ( T H I N K L E V E R A G E ) Assembler is a very low-level language C/C++ are medium-level languages Derivative Objective C used in Mac and iOS dev Java is a medium- to high-level object-oriented language used in enterprise software (EE) and in mobile (Android) PHP is a fairly high level language for web apps Haskell is a very high level functional language but not widely used yet 6. L A N G U A G E O R I E N TAT I O N Procedural languages - from 1950s to 1990s C, Fortran, PL/1, COBOL, Object Oriented - 1990s to C++, ObjectiveC, Java, C# Includes API or not? Functional: Haskell, OCaml, Erlang (rare in Mobile) Scripting 7. Scripting languages can be high-level, OO or not BASIC, VB, JavaScript, Python, Perl Special-purpose: PHP for web apps 8. HTML is the language for writing web pages By itself, not a programming language With JavaScript and CSS, it is HTML5 takes it further, provides access to graphics, GPS, local storage Many mobile apps built this way! PhoneGap/Cordova most common packaging tool 9. Software Devs use different methodologies too Like: building cars on a factory assembly line vs in a small prototype shop Cheapest cars are made in factories Luxury cars in-between Fastest cars are hand-built (Hennessey Venom: 270 MPH/432kmh, $1,475,000 approx) 10. Development usually starts with Requirements Doc Development Cycles can be long or short Longest - 6-12 months - waterfall fails big and late Shortest - 1-2 weeks - Agile fail early and small, correct (steering) 11. Agile Development Process -- 12. M O B I L E D E V E L O P M E N T 2 13. T H E M O B I L E P L AT F O R M S As Mike ODell said (long ago, talking about Unix platforms): If you think there will ever be a single platform vendor, you should be out selling pencils. Android History, Versions, Phones, Tablets, Success iOS Not the first but the stylishest BB10? Windows Mobile? 14. A N D R O I D D E V Full Disclosure: I write books and teach courses on this The most popular mobile platform worldwide (counting phones, tablets, etc.) Standard language is Java, but dozens of others (encouraged) 15. I O S Apples mobile platform for iPhone and iPad Standard language is Objective C, others possible (discouraged) HTML5 (PhoneGap etc.) apps work here too 16. BlackBerry 7 was based on Java but is orphaned BlackBerry 10 apps written in C++ or HTML5 Microsoft Windows Mobile 17. C R O S S - P L AT F O R M ? Idea: write once, run on multiple platforms I have a one-hour talk on Cross-Platform. Summary: Its easy to do mediocrly, hard to do well HTML5 + PhoneGap will get you started; UX issues Xamarin Mono looks good See for a great example! 18. M E D I C A L S O F T WA R E 3 19. April, 1915 Fail 20. January 2012 Fail 21. July 6, 2013 Fail 22. 1980s Therac-25 Fail 23. Where does this disaster movie lead? People do stupid things We establish standards and/or pass laws People still do stupid things, but less often Transportation, building, and medicine get greatest scrutiny Not to mention politics,wars to end all wars, We dont give up on technologies even when they sometimes fail: we must learn and move on For better or worse, we regulate 24. IEC 62304 "Medical device software: Software life cycle processes" International Electrotechnical Commission, Geneva, Switzerland Mandates a Quality Management System, Risk Mgmt, Software Safety Classification Describes software dev process: planning, requirements, architecture, software design, unit implementation & testing, system testing, release, maintenance. Emphasis on risk management, problem resolution 62304 not a requirement, but a "gold sticker" Due to be updated: 2e due 2014-01-31 25. ISO 13485:2003 ISO std for "Medical devices: Quality management systems" Adopted as "National Standard of Canada CAN/CSA-ISO 13485:03" Applies to an organization; harmonized with ISO 9000 certification but specific to medical devices Not technically mandatory, but the easiest way to medical device approval for licensing Focus: documenting all the steps of development 26. 13485 Requirements for a Quality Management System Focus is on documentation and risk mitigation Requires: Project charter Product Requirements Document Design and Development Plan Verification/Test Plan Risk Management Plan Design Files History hardware and software change logs Product Change Management process documentation Extra requirements for implantable devices, sterile devices/supplies, etc., in the medical area. Get expert consultant/auditor involved early! 27. 13485 Requirement for Control Using outside services not under your control Not allowed (unless 13485 certified, or you audit) e.g., we had to switch from private account on public, to GitHub Enterprise in-house, on our own server In-house contractors OK if individuals are trained in, and agree to follow, 13485 process Outsourcing Possible - Only to reputable companies that are 13485 certified Offshoring A definite no-no as you cannot usually reliably verify their processes 28. Health Canada Regulations SOR/98-282 supporting Canada's "Food and Drug Act" regulates medical devices Four categories (I is least risk, IV is most); 6 pages of rules Examples: Class I: Physical contact e.g., surgical instruments Class II: Full-time contact, some invasiveness, e.g., contact lenses, ultrasound scanner Class III: More invasive, deep implantation, e.g., orthopedic implants, hemodialysis machines Class IV:Total dependence, e.g., cardiac pacemakers 29. FDA United States Food and Drug Agency USA Your biggest market? FDA's Center for Devices and Radiological Health (CDRH) regulates Medical Devices Class I: General controls, e.g., surgical instruments Class II: General controls with special controls: performance expectations w/ no harm, e.g., hemodialysis machines Class III: General controls and premarket approval; most risk, e.g., cardiac pacemaker 30. F D A VA R I E T I E S O F M O B I L E A P P Peter Weinstein of the Centre describes the FDA listing what types fall into what buckets: 1. Apps that the FDA regulates 2. Apps they do not consider medical devices 3. Apps they will exercise enforcement discretion (i.e., FDA will ignore for now) Examples: Ignore apps that enable, during an encounter, a health care provider to access their patients personal health record (health information) that is either hosted on a web-based or other platform Apps that Allow health care providers to communicate in a secure and protected method are NOT medical devices As usual their approach leans heavily on intended use and risk, but tries to balance these concerns with innovation (bucket #3). 31. So where does this leave mobile apps? HC: If the medical device can be used normally without the need for the computer or smartphone, then the software on the computer or smartphone is not part of the medical system, is not a medical device, and is therefore not regulated. This is the case for our application bant. The meter can operate without bant, so bant is not medical device. FDA "accessory rule": a smartphone connected to medical device creates a medical system. The software on the computer and/or smartphone is also a medical device and must be licensed. In either country, software providing "decision-making" or "sophisticated decision-support can be ruled a medical device. E.g. software that recommends a a diagnosis, therapeutic course of action, medications, etc. that could be potentially life-threatening given errors in the software. Such software must be built using a quality system (ISO13485) and obtain a license as a medical device. 32. Canada Health InfoWay Quasi-government body funded by Govt of Canada In support of adoption of technology, EHR/EMR, etc. "Infoway works as a strategic investor of funds provided by the Federal Government, in collaboration with the provinces and territories." e.g, disburses funding to researchers and startups Certification, testing, working with startups 33. Continua Works on standards for inter-operability of medical devices and controllers (smartphones, tablets, computers) Holds inter-operability tests around the world All major equipment vendors are on-board with this 34. IEEE Institute for Electrical and Electronic Engineers publish standards for electronic communications Ethernet 802.11 Currently working on standardization for communication with Insulin Pump and Glucometer, to allows pluggable components in JDRF Artificial Pancreas program Two of these standards being developed by Centre staff! 35. Organizational Regulations and REB's University and Hospitals have own rules about e.g., experiments Research Ethics Board must approve any experimentation involving human subjects, no matter how simple E.g, we can't even do "coffee shop prototyping" without REB! Unless it's for a new app For existing app, need approval, must document, must use Change Reporting (13485) for resulting changes 36. W H AT W E V E C O V E R E D Overview of the development processes Health Apps can be medical devices (regulated) or other (unregulated) Ask a lawyer!! 37. C E N T R E F O R G L O B A L E H E A LT H I N N O VAT I O N , U H N , T O R O N T O A research group of ~70 devs, PhDs in HF, engineers, designer


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