Regulation and Law

Which state, federal, and international law and regulatory guidance must be adhered to in our research?

1. Have we examined the terms of service and end user license agreements (EULAs) for each of the vendors and software applications involved in our research?

2. Have we determined which data we collect will be considered personal health information (PHI)?

3. Have we ensured compliance with HIPAA privacy requirements, as well as state data privacy laws and applicable international privacy laws?

Resources:

FDA In Brief: FDA brings additional efficiency and modernization to regulation of digital health, as part of the Digital Health Innovation Action Plan

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-brings-additional-efficiency-and-modernization-regulation-digital-health-part-digital

List of FDA Guidance Documents with Digital Health Content

https://www.fda.gov/medical-devices/digital-health/guidances-digital-health-content

Fostering Medical Innovation: A Plan for Digital Health Devices

https://www.fda.gov/news-events/fda-voices/fostering-medical-innovation-plan-digital-health-devices

Digital Health Innovation Action Plan

https://www.fda.gov/media/106331/download

Statement on new steps to advance digital health policies that encourage innovation and enable efficient and modern regulatory oversight

https://www.fda.gov/media/109618/download

FDA permits marketing of mobile medical application for substance use disorder

https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-mobile-medical-application-substance-use-disorder

Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act

https://www.fda.gov/media/109622/download

General Wellness: Policy for Low Risk Devices

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices