‘Over regulation’ could hinder health app industry, advocates say

AirStrip President Matt Patterson gives a demo on how his company's software can allow doctors to remotely access a patient's records. (Courtesy of the committee)

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Health care apps offer doctors new ways to help patients outside the office, but too much federal control could stymie the technology’s growth in the long term, a panel of experts testified.

“Appropriate regulation can help to keep patients safe; over regulation and lack of clarity in a changing landscape will stifle innovation,” said University of Pittsburgh dermatologist Dr. Laura Ferris in her written statement for a House Energy and Commerce Committee hearing Wednesday.

During the hearing, lawmakers noted the ever-growing market of phone apps has shaken up health companies by allowing doctors to remotely access patient information or even conduct tests. It helps patients, too, they said. With these apps, patients can get diet advice or a diagnosis — or access their health records on their phones.

And while too much regulation could stifle innovation, policymakers still must ensure that the software doesn’t do more harm than good, Ferris said.

Ferris studied three publicly available apps that claimed to recognize cancerous skin moles and found they missed one-third to 90 percent of moles related to melanoma, a type of skin cancer. While the Federal Trade Commission shut down these apps, Ferris said she wanted to be sure a few bad apples didn’t ruin it for the others.

Maintain privacy is also a concern, panelists said. Matt Patterson, president of a mobile health care data app called AirStrip, also lamented the lack of guidance in the Health Insurance Portability and Accountability Act, a major health law to safeguard patients’ health information. He noted HIPPA’s guidance on mobile apps has not been updated since the iPhone was released in 2007.

“This persistent lack of clarity around HIPAA applicability in a mobile environment (for example, the use of texting or storing data in the cloud) prevents many patients from benefiting from these services,” he said in his written statement. “As a result, clear guidance does not exist to explain how physicians and patients can text or email each other appropriately.”

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With data so readily available, manufacturers also must do more to be sure records are secure and only accessed by doctors, said Diane Johnson, a senior director at Johnson & Johnson.

During the hearing, Patterson gave a demonstration of his company’s software, which gives doctors 24/7 digital access to their patients’ medical records. From the committee floor, Patterson showed how the software instantly provided doctors information about a patient’s medical history and monitors their well-being.

Committee Chairman Rep. Michael Burgess, R-Texas, noted that health apps have the “potential to radically improve health care.” A practicing physician, Burgess commended apps like AirStrip and noted he had a Food and Drug Administration-approved electrocardiogram monitor on his smartphone. But he emphasized Congress would need to step in if the industry didn’t do enough to police privacy and security.

“It is critical that every actor in this space start by addressing privacy and security. If industry fails to do this then Congress will be forced to address it,” he said. “And unfortunately, whatever Congress would do would likely limit the potential in this space and limit the success of the health apps market.”

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Department of Health and Human Services (HHS), Departments, Health apps, Health IT, Tech
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