Lawmakers lobby feds to update regulatory guidance for mHealth apps

Two congressmen are asking the Department of Health and Human Services to develop "clear, easily accessible and up to date regulatory guidance" regarding mobile applications and requesting the federal agency update online technical compliance guidance to help app makers adhere to the Health Insurance Portability and Accountability Act.

"Many companies creating mobile health apps have told us that they want to fully comply with HIPAA regulations, but have difficulty confirming that they have done so because current regulatory guidance does not cover technologies that they are using," Reps. Tom Marino (R-Pa.) and Peter DeFazio (D-Ore.) wrote in a letter sent Thursday to Sylvia Mathews Burwell, secretary of HHS.

The letter suggests several steps the agency should undertake to help mobile app developers ensure software is compliant with HIPAA--including identifying implementation standards to avoid enforcement activity and conformity to regulations, clarity on HIPAA requirements for storing encrypted health data in clouds and remote storage centers and compliance help to make it as easy as possible for app makers to meet federal rules.

"This would allow American healthcare companies to be more competitive in foreign and domestic markets and would provide an economic incentive to follow important safeguards for the benefit of patients," the lawmakers write.

The congressmen's action is in direct response to a letter sent last week to Marino from ACT-The App Association, which represents more than 5,000 mobile app players. The group is striving to drive change in the regulatory environment regarding mHealth app development given regulations have not kept up with the growth of mHealth technology.

The letter also comes on the heels of a new ACT-The App Association report, released in part this week, regarding the mobile app industry which the report states has become a $68 billion industry in only six years, with current revenues expected to hit $4 billion this year and $26 billion in three years. The exponential growth is driving huge job creation, states the report, with 56 percent of app developer companies currently hiring. There is an average of 19.8 openings needing to be filled at those hiring businesses, according to the report.

ACT's Executive Director Morgan Reed said his group is pleased lawmakers are responding so quickly to its requests and are strongly committed to mHealth innovation.

"The app industry has long looked to Congressmen Marino and DeFazio for their leadership on tech issues. We are grateful for their support to create a better regulatory environment that encourages innovation in this life-changing marketplace. HHS needs to know that they have champions both in Congress and industry that want to see HIPAA improved," Reed said in a statement.

For more information:
- read the congressmen's letter (.pdf)
- read ACT's industry report (.pdf)

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