Category: Mobile Health

FDA Releases Digital Health Guidance to Spur Innovation

On December 7th, the Food and Drug Administration (FDA) announced the release of a much-anticipated suite of guidance documents that loosen the regulatory requirements for digital health technologies.  By clarifying what is – and what is not – subject to regulation, this set of guidance could create significant opportunities for […]

FTC Announces Guidance for Developers of Mobile Health Apps

Chairwoman Edith Ramirez of the Federal Trade Commission (FTC) announced the release of new guidance directed towards developers of mobile health apps (the “Guidance”), while speaking today at the International Association of Privacy Professionals (IAPP) conference in Washington, DC.  The Guidance is a tool created in collaboration with the FTC, the […]

HHS Launches HIPAA Platform for Medical Application Developers

On Monday, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released an online platform designed for use by developers of mobile medical applications (apps).  The site allows users to submit questions regarding compliance with the Health Insurance Portability and Accountability Act (HIPAA) and to access […]

HIPAA FAQ Series: Do You Need a BAA with Your Cloud Storage Provider?

This week, the HIPAA FAQ series continues with another topic about business associate agreements (BAAs). As most Covered Entities and Business Associates know, in the event that a Covered Entity utilizes a service provider that may have access to Protected Health Information (PHI), a BAA is required. Further, in the event […]

HHS to Address Lack of Clarity Regarding Mobile Health

A letter from the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights to Rep. Peter DeFazio (D-Ore.) signals an intent to move forward with providing clearer regulatory guidance relating to the Health Insurance Portability and Accountability Act (HIPAA) rules addressing mobile health app developers.  The letter, […]

FDA Cybersecurity Workshop for Healthcare

On October 21-22 the U.S. Food and Drug Administration (FDA), in collaboration with the U.S. Departments of Health and Human Services and Homeland Security, conducted a public workshop entitled “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.”  The FDA held this public workshop in order to bring together stakeholders in […]

Lawmakers Call to Clarify HHS’ Mobile Medical App Regulation

The mobile medical application marketplace has developed into a $68 billion industry; however, the U.S. Department of Health and Human Services (HHS) has not yet updated guidance regarding the Health Insurance Portability and Accountability Act’s (HIPAA) application to app developers that collect and use sensitive personal data. In response to […]