Congressional hearing covers obstacles, achievements of mobile health apps

Several witnesses discussed how the drop in providers combined with the increase in the aging population and chronic disease are driving innovations in mobile health during a Congressional Committee on Small Business hearing focused on mobile health apps.

Mobile medical apps are an exciting area of innovation, said Rep. Janice Hahn (D-Calif.) during the June 27 hearing. They hold “tremendous promise for small businesses, healthcare providers and patients.”

Alan Portela, CEO of Airstrip, discussed how his company’s app can, for example, get a heart attack patient’s data to a cardiologist right from the ambulance so that the care team is ready to provide the most appropriate treatment to that patient upon arrival at the hospital. The app has resulted in a reduction of intervention time of up to 30 minutes.

Portela said the FDA “made us relevant and the Department of Defense (DoD) made our patient data secure," citing a security certification from that organization. “We urge the FDA to provide guidance…the lack of guidance is encouraging medical device manufacturers to offer inferior solutions. That’s hurting us as a small business and as patients.”

Rep. Chris Collins (R-NY) asked the witnesses how they are managing the privacy and security of patient data. Portela said Airstrip recently earned DoD Information Assurance Certification and Accreditation Process (DIACAP) through which they receive regular updates on security vulnerabilities. He called for the industry to bring some of that certification into the private sector.

Hahn asked the witnesses about interoperability and how it impacts their efforts. Sabrina Casucci, PhD candidate, Industrial and Systems Engineering, University at Buffalo, who had discussed the app for discharge planning she is in the process of designing with her colleagues, said there are no unified or agreed upon standards for these different technologies to communicate. “Integration of our system is really key. We need to talk with everybody.”

Portela disagreed, saying that we are not lacking the standards, but the standards need to be enforced. “Vendors have the tendency to protect the data to preserve some of the advantages they have.” He said vendors really only support the continuity of care document standard which is “a very small subset of patient data. The real data you have to get from interfacing with each vendor. Vendors need to be forced to collaborate.”

Rep. Blaine Luetkemeyer (R-Mo.) asked the witnesses what barriers they face. Portela said that, as a cutting-edge company, the rules don’t yet exist. He said the FDA approval process is improving significantly but “we would like the FDA to recognize what we are trying to do as a leader in the industry. They need to make regulations so everybody has to comply with the same regulations.”

Keith Brophy, CEO of Ideomed, said he and his colleagues look forward to the clarity that FDA mobile health guidelines will provide. When asked what the government could do to help this industry, he said, “Bandwidth is beautiful.”

Collins acknowledged the obstacles the witnesses face: “Any time you’re on the cutting edge there will be bumps in the road.”