Congress urges HHS to update HIPAA mHealth guidance

The Department of Health and Human Services (HHS) is long overdue to update its HIPAA guidance to better regulate the rapidly evolving mobile health industry market, according to two House representatives.

Following up on a letter sent to him from ACT|The App Association, Rep. Tom Marino (R-Penn.), along with Peter DeFazio (D-Ore.), sent a letter to HHS Secretary Sylvia Mathews Burwell pointing out that the agency’s website outlining technical compliance with HIPAA has not been updated since 2006, “years before an app store existed, much less the modern mobile device.”

As such, companies both large and small are struggling to determine if their mobile health apps are in compliance with HIPAA regulations. Some have hired legal teams just to determine, with some level of certainty, whether their product is in compliance.

“In order to make sure that mobile health apps and other companies can in good faith comply with these [important] protections, we ask that HHS provide clear, easily accessible and up to date regulatory guidance for HIPAA compliance with regard to new technologies,” according to the letter.

The congressmen also called for:

  • The development of Implementation standards by the Office of Civil Rights to help companies conform to regulation and avoid enforcement action
  • Clarity on HIPAA obligations for companies that store data in the cloud
  • The assignment of HHS employees with technical expertise to regularly engage with companies in the emergent healthcare technology space.

Read the full letter.

 

 

Around the web

The American College of Cardiology has shared its perspective on new CMS payment policies, highlighting revenue concerns while providing key details for cardiologists and other cardiology professionals. 

As debate simmers over how best to regulate AI, experts continue to offer guidance on where to start, how to proceed and what to emphasize. A new resource models its recommendations on what its authors call the “SETO Loop.”

FDA Commissioner Robert Califf, MD, said the clinical community needs to combat health misinformation at a grassroots level. He warned that patients are immersed in a "sea of misinformation without a compass."

Trimed Popup
Trimed Popup