Building Consumer-Facing Health Devices and Apps and Doing it Right
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John Sharp presented on building consumer-facing health devices and apps. He discussed key points like developing solutions that solve problems, understanding the market, prototyping and piloting before adopting and scaling, understanding the regulatory pathway, the importance of evidence, integrating data, and changing health behaviors. He also provided information on partnering with health systems, getting products to scale, involving patients in co-design, the FDA's digital health precertification program, developing digital evidence, and standards for data integration like FHIR and Continua Design Guidelines.
Building Consumer-Facing Health Devices and Apps and Doing it Right
- 1. Building Consumer-Facing Health Devices and Apps and Doing it Right HIMSS Northern Ohio Chapter 5/23/19 John Sharp, Director @PCHAlliance
- 2. 2 Personal Connected Health Alliance Help people make health and wellness an effortless part of daily life • Focused on consumer-facing health technology • More than 80 corporate members • Key initiatives: digital therapeutics, behavior change, aging and tech and innovation • Connected Health Conference – October 16-18, 2018, Boston • A HIMSS Innovation Company
- 3. 3 My experience • HIMSS staff since 2013 • Previously at the Cleveland Clinic in Clinical Research Informatics • Advisor for Healthbox and the Medical Capital Innovation Competition • Adjunct Professor, Health Informatics, Kent State University
- 4. 4 Key Points Today • Developing an app or device which solves a problem • Which integrates into clinical workflow or consumer’s lifestyle • Understand the market • Prototype, Pilot, Adopt, Scale • Understand the regulatory pathway • Importance of Evidence • Changing Health Behaviors • Data integration
- 5. 5 Developing something that solves a problem Developing an app that solves a problem
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- 9. 9 Understanding the Market • Telehealth is the largest growth area • Remote monitoring still a small percentage (3% by one report) but may grow as payment models change including share risk • Virtual coaching is hitting its pace – virtual physical/occupational therapy including VR, Diabetes Prevention Programs, chronic disease management • Employee wellness using wearables is scaling – Walmart app for employees, Aetna/Apple partnership, payers and employers partnering with Fitbit
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- 11. 11 Prototype Pilot Adopt Scale
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- 13. 13 Partnering with Health Systems Good news – many have innovation centers as a point of entry Find a physician or administrator as a champion Not your typical funding pitch Do they have the problem you are trying to fix? Does it save time for physicians? Is there a potential ROI? Does it take cost/complexity out of the system? Does it integrate with their EMR or other key systems?
- 14. 14 Getting to Scale • Right partners • Technology that scales • Wearable production • Managing thousands of users • Business model • Appropriate funding • Turn Solutions into Strategy • Potential exit See Can We Achieve Scale in Innovation? – NEJM Catalyst 2017
- 15. 15 Involving Patients in Co-Design In all stages of designing consumer-facing apps and devices Partnerships with: • WEGO Health • Savvy Coop • Society of Participatory Medicine
- 16. 16 Now part of the HIMSS family Innovation consulting Fund management/Strategic Investing Commercialization Analysis Headquartered in Chicago
- 18. 18 Clinical Apps and Devices Software as a Medical Device (SaMD) – now defined by the FDA software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software Mobile apps that meet the definition above are considered SaMD
- 19. 19 Software as a Medical Device – Examples • diagnosis, prevention, monitoring, treatment or alleviation of disease or injury • provide means and suggestions for mitigation of a disease (clinical decision support) • be an aid to diagnosis, screening, monitoring, determination of predisposition; prognosis, prediction, determination of physiological status.
- 20. 20 Regulatory–Clinical–Technology risk paradigm Digital health: a path to validation Nature Digital Medicine, 2019
- 21. 21 Digital Health Software Precertification (Pre-Cert) Program
- 22. 22 Who Is Currently Involved in the Pre-Cert Pilot Program? • Phosphorus • Roche • Samsung • Tidepool • Verily •Apple •Fitbit •Johnson & Johnson •Pear Therapeutics
- 23. 23 When to Conduct a Study and IRB Type of Study Conduct a study? Need IRB review? Clinical efficiency Yes, validation No Clinical Decision Support Yes Yes, since it directly impacts patient care Patient Education Maybe Apply for an exemption from the IRB Wellness device Yes, validation and outcomes Probably not Medical device used for remote monitoring Yes, validation and outcomes Yes Mobile app to manage a chronic condition Yes, validation and outcomes Yes Mobile device to manage a chronic condition Yes, validation and outcomes Yes, may also be subject to FDA review IoT or supply chain Some validation No
- 25. 25 Deloitte Center for Digital Health Solutions
- 26. 26 Digital Medicine: A Primer on Measurement in Digital Biomarkers, 2019
- 27. 27 Network of Digital Evidence Combine the rigor of Evidence Based Medicine (EBM) with emerging healthcare technologies to help create evidence-based digital medicine More than 40 health systems participating Monthly newsletter www.nodehealth.org New article on Clinical Validation in Digital Biomarkers
- 28. 28 The Challenge of Health Behavior Change The experts - Society of Behavioral Medicine A multidisciplinary organization of clinicians, educators, and scientists dedicated to • promoting the study of the interactions of behavior with biology and the environment • then applying that knowledge to improve the health and well-being of individuals, families, communities, and populations. • From medication adherence to weight loss to smoking cessation and more… • www.sbm.org
- 30. 30 Continua Design Guidelines Open source development model – the Continua Design Guidelines are universally accessible, non-proprietary and not for profit Flexibility – designed to provide maximum choice for developers and end users (healthcare buyers, individual clinicians and consumers) Using FHIR standard http://www.pchalliance.org/continua-design-guidelines
- 31. 31 Apple Health Kit As an EHR and app integration tool. When a customer provides permission for your app to read and write health and activity data to their Health app, your app can become a valuable health data source. Also uses FHIR Instructions for how to integrate with Apple Watch https://developer.apple.com/healthkit/
- 32. 32 Fast Healthcare Interoperability Resource Exchangeable content is defined as a resource • A common way to define and represent them, building them from data types that define common reusable patterns of elements • A common set of metadata • A human readable part Uses RESTful Web services Enables integration of Patient Generated Health Data
- 33. 33 What’s Next? Technology uses yet to be discovered More functions for wearables Implantables, ingestibles Apps for more conditions Digital Health Platforms Broader application of VR/AR New business models More evidence including on health behavior change More customer convenience Broader partnerships Leading to Digital transformation
- 34. 34 Key Points Today • Developing an app or device which solves a problem • Which integrates into clinical workflow or consumer’s lifestyle • Understand the market • Prototype, Pilot, Adopt, Scale • Understand the regulatory pathway • Importance of Evidence • Data integration