mHealth Reports

Draft Guidance

On July 11, 2011 the FDA released this draft guidance to inform interested parties about how they intend to apply their regulatory authorities to mobile applications. Interested parties were invited to submit comments in response to its release.

White Papers and Reports

Federal Trade Commission: Mobile Privacy Disclosures – Building Trust Through Transparency 

Bipartisan Policy Center Report: An Oversight Framework for Assuring Patient Safety in Health Information Technology

Evaluating mHealth Adoption Barriers: Privacy and Regulation

iPads, iPhones, Andriods, and Smartphones: FDA Regulation of Mobile Phone Applications as Medical Devices

mHealth in an mWorld: How mobile technology is transforming health care

Allied Health World Inforgraphic: Smartphone = Smart Healthcare?

Pew Report – Mobile Health 2012

The mHealth Regulatory Coalition has developed a white paper entitled “A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth”. This 60-page paper focuses on a single question: What mHealth hardware and software will FDA regulate?

Brian Dolan at has published a 50 page report Brad Thompson wrote on FDA Regulation of mHealth, as a free download. We recommend reading the report (PDF) for background.

California Healthcare Foundation Report: How Smartphones are Changing Health Care for Consumers and Providers

McKinsey & Company Report mHealth: A new vision for healthcare:

HHS Text4Health Task Force

The Text4Health Task Force was established by the Department of Health and Human Services in November 2010 in order to provide recommendations to HHS on the topic of promoting text messaging initiatives that would deliver health information to individuals’ mobile phones.

  • The Text4Health Task Force’s recommendations can be found here:
  • Co-chairs:
    • Todd Park, HHS, Immediate Office of the Secretary
    • Wanda Jones, DrPH, HHS, Office of the Assistant Secretary for Health
    • Julia Eisman, MPA, HHS, Office of the Assistant Secretary for Public Affairs

FCC mHealth Task Force

The mHealth Task Force was the product of the FCC’s 2012 mHealth Summit; participants in the summit recognized the government’s need for assistance in transitioning to a healthcare system powered by mobile health solutions, and the task force was formed to produce a guidance document to influence future regulatory action.  The FCC responded positively to the recommendations, and it is clear that they will play a large role in shaping future policy decisions.

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