Medical app makers were back on Capitol Hill Thursday talking with lawmakers about the regutory challenges and needs for mobile medical apps. Compared to the House Energy and Commerce’s three-day hearing back in March, though, the conversation was much less heated.
Four small business owners testified before the Small Business Subcommittee on Health & Technology, who asked what mobile health entrepreneurs wanted and needed from lawmakers on the business side.
Alan Portela, CEO of AirStrip Technologies, said he was probably one of the rare vendors who wanted more regulation from the FDA. “What we really want to urge as part of this committee is for the FDA to provide guidance on the regulation of diagnostic quality medical device mobility,” he said. “Lack of guidance is encouraging medical device manufacturers to offer inferior solutions and give them to customers without the proper clearance.”
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Sabrina Casucci is a University of Buffalo doctoral candidate who’s part of a team whose discharge planning app won second prize in GE’s Hospital Quest competition. She said interoperability is top concern for her team. “Improving interoperability standards will ensure that healthcare providers can choose a solution that best fits the needs of their patients and not the needs of their health information technology systems,” she said in her testimony.
The standards are there, they just need to be enforced, Portela noted. Keith Brophy, CEO of Ideomed, said many mobile app vendors build solutions that can be integrated into various IT systems if the other side of the equation – the EMR vendors – has the bridges for that integration.
Another important component to interoperability, according to Dr. Chris Burrow, EVP Medical Affairs at Humetrix, is the exchange of data between providers and patients. “The patient/consumer exchange model that we embody is this other idea that if everyone has access to a summary medical record that they can carry on their mobile device, that will help solve the interoperability problem,” he said.
On a more fundamental level, Rep. Janice Hahn (D-CA), pointed out that almost half of U.S. adults don’t have a smartphone and asked how lawmakers can help make sure those people aren’t being left behind. Portelo noted that a lot of mobile health, even though it helps patients, works by supporting the physicians. “We are the silent partner of the patient; we support the caregiver, so I am more about the physicians being able to get access to the data for all the patients anywhere at any time,” he said. “Anything that can support caregivers to do care coordination through mobile technology I think is the area where we need the most help. Reimbursement on the Medicare side is very important for that.”
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Brophy closed by underscoring the importance of bandwidth in the mobile health movement. “A nation with great bandwidth is a strong nation today.”
View the whole hearing here.
[Photo credit: Flickr user ttarasiuk]
