Draft Guidelines Released for the Responsible Use of Wearables, Smartwatches and Health Apps

With consumer use of wearables, smart pill bottles, health apps and other forms of personalized health technology rapidly increasing, concerns around data privacy, proper interpretation of health information and data stewardship are also on the rise.  In response, the Vitality Institute, along with Microsoft Corporation, the University of California, San Diego, and other stakeholders, are developing a set of industry guidelines to address the legal, social and ethical concerns associated with the development and use of the technology and the data it generates.  The guidelines build on existing best practices to create a standardized approach.  A draft of the guidelines is being released online today, opening a three month public comment period before the guidelines are finalized.

“I urge anyone with an interest in the future of health technology to review the guidelines and comment.  This includes consumers who use wearables, smartwatches and health apps, along with leaders of the companies that develop, market and distribute these products,” said Derek Yach, executive director of the Vitality Institute and senior vice president of the Vitality Group.  “Personalized health technology has great potential to benefit the health of countless individuals and it is critical that we proactively address these legal, social and ethical challenges so that potential benefit is not hindered.”

The draft responsibility guidelines make six recommendations that call on personalized health technology to:

  1. Protect the privacy of a user’s health data
  2. Clearly define who owns a user’s health data
  3. Make it easy for users to accurately interpret their data
  4. Integrate validated scientific evidence into product design
  5. Incorporate evidence-based approaches to health behavior improvement
  6. Be accessible to marginalized populations

“These responsibility guidelines provide a framework for protecting consumers and treating them fairly and ethically.  I hope this comment period will open a global dialogue on these issues and help create the strongest possible guidelines,” said Kevin Patrick, MD, MS, a professor and researcher at the University of California, San Diego and one of the authors of the guidelines.

“Innovative personal health technology products are producing completely new categories of data and creating completely new challenges for developers, clinicians and users,” said Dennis Schmuland, MD, Microsoft’s chief health strategy officer for the U.S. Health and Life Sciences division and an author of the guidelines.  “Now, as we create guidelines to help the legal, ethical and societal considerations catch up to the innovation, I encourage my colleagues to review the guidelines and share their input.”

The public can comment on the draft guidelines by going to www.thevitalityinstitute.org/ELSI.  The comment period will close on October 15.  At that point, the guidelines will be finalized and shared with industry leaders.  A voluntary group of organizations will then pilot the guidelines and be independently monitored to ensure they are accountable for their actions.

About the Vitality Institute

The Vitality Institute is an evidence-driven, action-oriented research organization working to strengthen the evidence base around what works and what doesn’t work in health promotion and chronic disease prevention.  Its mission is to advance knowledge about the evolving science and art of prevention and health promotion in order to build healthier societies and reduce incidence of non-communicable diseases.  The Vitality Institute is an initiative of Discovery, a global financial services provider, and is part of Discovery’s commitment to health promotion and well-being programs.  More information is available at www.thevitalityinstitute.org. Follow the Institute on Twitter at www.twitter.com/VitalityInst or on Facebook at www.facebook.com/theVitalityInstitute.

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