I have posted information on this topic before here and here among other places on this blog. My rule of thumb is that if it touches your body and records information about it, it is subject to HIPAA regulations. Knowing that this does not fit the narrative presented by limited government advocates; that is where we are. Until Medicare and Medicaid are brought on board with coverage for wearables, this health benefit will remain a niche product and service.
For additional guidance on creating effective disclosures, check out the FTC’s .com Disclosures report. If you have a health app, don’t forget to consult the mobile health apps interactive tool, the FTC’s best practices guidance for mobile health app developers and the OCR developer portal. And when you’re telling consumers about how you share consumer health information, always remember the FTC Act as well as HIPAA (“Sharing Consumer Health Information?” 2016).
How do HIPAA security and privacy protections apply to wearable health technology and the health data it collects and stores?
Sharing Consumer Health Information? Look to HIPAA and the FTC Act. (2016, October 18). [Drupal 7]. Retrieved July 26, 2018, from https://www.ftc.gov/tips-advice/business-center/guidance/sharing-consumer-health-information-look-hipaa-ftc-act