Building Consumer-Facing Health Devices and Apps and Doing it Right
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The document discusses the development of consumer-facing health devices and apps, emphasizing the importance of solving health-related problems and integrating into existing workflows. It outlines key aspects such as market understanding, regulatory pathways, and the need for evidence-based approaches in digital health solutions. Additionally, it highlights the significance of partnerships, data integration, and the potential for innovations in healthcare technology.
Building Consumer-Facing Health Devices and Apps and Doing it Right
- 1. Building Consumer-Facing Health Devices and Apps and Doing it Right HIMSS Delaware Valley Chapter 3/21/19 Disruptive Technologies: The Next Generation of Healthcare John Sharp, Senior Manager @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 • Continua Design Guidelines for Patient Generated Health Data • 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 Prototype Pilot Adopt Scale
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- 11. 11 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?
- 12. 12 Is the IT department the wood chipper for Innovation?
- 13. 13 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
- 14. 14 Now part of the HIMSS family Innovation consulting Fund management/Strategic Investing Commercialization Analysis Headquartered in Chicago
- 16. 16 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
- 17. 17 Software as a Medical Device – Examples • diagnosis, prevention, monitoring, treatment or alleviation of disease • diagnosis, monitoring, treatment, alleviation of or compensation for an injury • investigation, replacement, modification, or support of the anatomy or of a physiological process • supporting or sustaining life • control of conception • 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.
- 18. 18 Digital Health Software Precertification (Pre-Cert) Program
- 19. 19 Who Is Currently Involved in the Pre-Cert Pilot Program? • Phosphorus • Roche • Samsung • Tidepool • Verily •Apple •Fitbit •Johnson & Johnson •Pear Therapeutics
- 20. 20 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
- 22. 22 Deloitte Center for Digital Health Solutions
- 23. 23 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
- 24. 24 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
- 26. 26 Continua Design Guidelines Authentic interoperability – connectivity requiring minimal effort on the part of the user 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) Wisdom of the market – the market in aggregate has more wisdom than any individual stakeholder; thus the Continua Design Guidelines are developed through a consensus process Now uses FHIR standard http://www.pchalliance.org/continua-design-guidelines
- 27. 27 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/
- 28. 28 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 Patient Generated Health Data on FHIR from Continua
- 29. 29 What’s Next? Technology uses yet to be discovered More functions for wearables Implantables, ingestibles Apps for more conditions Digital Health Platforms New business models More evidence including on health behavior change More customer convenience Broader partnerships Digital transformation
- 30. 30 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