Outdated federal regs may pose threat to mHealth innovation

As mHealth technologies develop new platforms there is one huge hurdle--outdated and confusing regulations, which pose a serious threat to innovation, according to Morgan Reed, executive director of ACT | The App Association.

"Without substantial changes, new technologies that can improve the lives of patients and the capabilities of their caregivers will remain out of reach to most consumers," Reed writes in a column at iHealthBeat.

From outdated guidance regarding HIPAA compliance and heavy-handed rules on what is not allowed to a lack of specific examples for improving patient access to information, federal health agencies are not keeping pace with mHealth technology, he writes.

"Unfortunately, regulatory agencies threaten to restrict the life-changing impact of mobile health. Slow to meet the challenges of advancing technology, regulators have left outdated or no-longer-relevant requirements in place, creating unnecessary complications and confusion," Reed says.

Reed's call for clearer regulatory insight comes about a month after his group lobbied a lawmaker to speed innovation and app development without sacrificing security and privacy protection. His call also offered three specific changes for the Department of Health and Human Services (HHS) to make regarding implementation of the Health Insurance Portability and Accountability Act (HIPAA). In quick response, Reps. Tom Marino (R-Pa.) and Peter DeFazio (D-Ore.) wrote a letter to HHS Secretary Sylvia Mathews Burwell asking for "clear, easily accessible and up to date regulatory guidance" regarding mobile applications.

Simultaneously, the issue of mobile medical app review and certification is spurring a healthy professional debate between physicians and highlighting pros and cons in how best to tap such tools while ensuring patient safety and data security.

In his column, Reed presents four specific recommendations for HHS to avoid being an "obstacle to progress." These include providing clear information of what's expected from mHealth vendors in light of HIPAA; clearly identified implementation standards for compliance; clarity regarding HIPAA rules on cloud-based data security; and greater transparency for mHealth developers.

For more information:
- read the column at iHealthBeat

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