The biggest challenges confronting mobile medical app entrepreneurs are interoperability and government regulations, according to witness testimony from four app developers at a June 27 hearing held by the House Small Business Subcommittee on Health and Technology.
"Increased governmental and industrial support for start-up organizations and health care researchers like us is needed, as is increased federal support of interoperability standards that enable communication between different information technology systems," testified Sabrina Casucci, an entrepreneur and Ph.D candidate in industrial and systems engineering at the State University of New York at Buffalo.
Casucci represented a team of graduate engineering students at the hearing that won second place in the Grand Prize round of the GE HealthQuest Challenge for the development of a new mobile app called Discharge Roadmap, which provides better and more timely communication aimed at patients and family caregivers throughout the hospital discharge process.
"In order for technology-enabled solutions, such as Discharge Roadmap, to succeed, the solutions must be able to communicate with existing hospital information systems," said Casucci. "However, the current lack of a unified data structure and communication protocols severely limits this communication ability. Improving interoperability will ensure that healthcare providers can choose a solution that best fits the needs of their patients, and not just the needs of their current health information technology systems."
Alan Portela, CEO of San Antonio, Tex.-based AirStrip, agreed that the interoperability challenge continues to "plague" hospitals and health systems, with industry "over-promising" and "under-delivering" when it comes to vendors "playing nice in the sandbox," integrating systems, medical device interoperability and making data across the continuum available in a simple and cost-effective way.
"The answer to this challenge is mobility," testified Portela. "With today's changing models of care, mobility enables coordination across multiple facilities and geographies, as clinicians increasingly need to make or discuss real-time decisions beyond the bedside. Mobility also overcomes what we've always known as the traditional barriers to interoperability--disparate data sources on the back end and conflicting and varied user preferences on the front end."
Portela said AirStrip's approach to address interoperability is to comply with interoperability standards such as HL-7, Continuity of Care Document, and others.
"A world where interoperability is achieved through mobility should not only provide secure, near-real-time data about a patient from any source across the care continuum – from admit to discharge and beyond – but it should also offer the 'big picture' data health systems need to make broader decisions about their operations and ultimately, their financial future," he stated.
The purpose of the subcommittee hearing was to highlight the "groundbreaking" apps that entrepreneurs are developing and how the technology is changing the face of U.S. healthcare.
"Entrepreneurs have pioneered apps for purposes as varied as tracking fitness routines to reading a patient's digital images," stated Rep. Chris Collins (R-N.Y.), chairman of the Health and Technology subcommittee, in his opening statement. "To bring these products to the public, small businesses must navigate a complex web of challenges: product financing, marketing, taxes and regulations."
Nevertheless, Portela was the only industry witness to testify that the "FDA should include many more mobile medical device apps under its jurisdiction"--a unique position among mHealth software developers, who usually advocate for less, not more government regulation.
"Many vendors today are trying to question the need for FDA involvement with an argument around whether innovation is being slowed down or stifled outright," he testified. "We feel strongly about the need for the FDA to regulate, from both diagnostic quality and security perspectives, mobile applications that handle vital information for remote monitoring systems."
Portela made the case that all mobile medical device apps displaying near and real time medical device waveforms and parameters data need careful regulation. In addition, he asserted that "accessories" to primary devices, which have potential failure points, should also be evaluated due to the fact that software "accessories" to primary devices do not currently require separate clearance by FDA.
"Traditionally, the FDA has focused on regulating hardware devices, but companies producing software-only medical device apps or even websites need to be regulated as well," he argued. "Today, many websites or apps have crept into FDA-regulated territory without scrutiny by adding features or functionality that position them as clinical decision support systems."
Dr. Christopher Burrow, executive vice president of medical affairs for Humetrix, a small business in Del Mar, Calif., told the subcommittee that the regulation that affects his 15-year-old company the most is HIPAA. Humetrix's iBlueButton app is designed to be fully compliant with HIPAA in terms of encryption, Burrow said.
However, when it comes to apps capable of displaying mission-critical patient data, Portela believes app developers should obtain security certification levels that go beyond the existing HIPAA requirements and FCC security regulations (Open SSL). "HIPAA, today, and the FCC with the Open SSL standard, they primarily direct the security to the application level but they don't do that on the operating system level so much," he said. "What I recommend is that we take a look at what the [Department of Defense] is doing and bring in some of that certification process into the private sector."