Big week in health IT

Finally! The FDA has issued long-awaited final guidance for mobile health applications. In a move that should surprise no one, the agency plans a risk-based approach for enforcing mobile apps.

The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.

The policy, said the agency, aims to protect patients while encouraging innovation. I know many vendors were hoping that final guidance would offer some clarity as they move forward with their efforts—it will be interesting to see if and how the guidance impacts the future of medical mobile apps.

Also this week, we learned that another member of Office of the National Coordinator of Health IT leadership is leaving. Just after National Coordinator Farzad Mostashari, MD, ScM, announced he will step down—his last day is Oct. 5—Principal Deputy David Muntz, MBA, has submitted his resignation. How might these staffing changes impact the future of health IT?

HIMSS held its second annual Privacy & Security Forum this week and Office for Civil Rights (OCR) Director Leon Rodriguez provided some insight on the office’s future enforcement plans. There will be a strong emphasis on patient interests, he said.

Rodriguez said he plans to leverage his office’s budget to fund audit activity and breach analysis. Speaking of which, he said OCR has learned a lot from its pilot audit project. “We’re in the midst of planning our process for the coming year of how to conduct a permanent audit program. We’re hiring dedicated audit personnel and will work with contract auditors as well.” The pilot only allowed for audits of 115 entities. “We want to reach more than 115 entities annually, so we need to think about how to leverage our funds. You’re going to see much more targeted audits and you’ll see, perhaps, the areas we focus on change year by year depending on where we see vulnerabilities. Risk analysis will be one focus of our audit activity but as new vulnerabilities are uncovered, we’ll see others come to the forefront.”

These were some pretty signficant developments for one week, wouldn't you agree? Please share your experience.

Beth Walsh

Clinical Innovation + Technology editor