BOSTON—“It’s a tremendously exciting time for mHealth,” said Adam Landman, MD, CMIO, health information innovation and integration at Brigham and Women’s Hospital in Boston, speaking at the mHealth + Telehealth World 2014. “It’s really fueled by amazing growth and utilization of mobile devices.”
However, with more than 20,000 mobile apps available, it’s hard for potential users to wade through them all. “There are wonderful apps out there but it’s very difficult for consumers to understand what they do. And, when healthcare is involved, we want to make sure these are accurate and evidence-based tools.”
Adam Powell, PhD, lecturer in health informatics at Northeastern University, said the FDA is taking a reasonable approach with its targeted oversight plans that focus on “functionality rather than platform.” It’s such as fast-changing environment “but the FDA doesn’t need to keep up with every little change.”
FDA’s role has some positive impacts, said Powell. “It can potentially increase investor and developer confidence. They don’t want to spend a ton of money if they don’t know how a regulator is going to act. People can more comfortably make large investments.”
FDA oversight also is good for public safety because it creates a barrier to entry for those more challenging apps and may make it easier to get payer reimbursement.
"One technology we’re really excited about is the advent of Google Glass,” said Kevin Littlefield, CISSP, information security officer at Brigham and Women’s Hospital. “It’s a technology that’s truly revolutionary or at least extremely evolutionary.” With its focus on visual presentation rather than screens and keyboards, he said it’s the first time technology has structured itself to adapt to the way humans act.
This new paradigm raises new privacy and security questions, however. “Tradition authentication methods might not work,” said Littlefield, because user access control requirements assume usernames and passwords but Google Glass doesn’t have a keyboard to input a password.
Entities other than the FDA could play a role in advancing the safety of mobile health apps, said Powell. These entities also could make recommendations on how to develop robust apps for consumers, said Landman.
Privacy continues to be challenging for providers because it’s done at the state level and there is no consistency, said Littlefield. “From Partners’ perspective, we’re trying to structure our information security program by looking at the right way of handling information. We’re looking at it as how can we better serve our patients and employees. We’re taking a technology- and regulatory-agnostic approach.”
Littlefield added that the complex regulatory environment is challenging for innovation. “The real challenge is to take those regulations and build off them to drive the innovation we can deliver for our mHealth and telehealth solutions.”
“When it doesn’t make sense,” said Landman, “just think about what would be best for the patient and do the safe thing.“