Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Health Apps Boom While Regs Lag."
Following is an excerpt:
One possibility is to create a health IT safety center to oversee the mhealth industry, except for those high-risk products that would have to get FDA approval. The center would function along the lines of the National Transportation Safety Board, which can subpoena records and testimony following accidents and near misses but has no enforcement power. …
But even some voices within the industry are beginning to call for more intensive oversight and FDA scrutiny. They worry that if a few apps go spectacularly wrong, it could wreck a multibillion-dollar industry.
"What if someone doesn't see a doctor because flawed software missed the melanoma?" asked Bradley Merrill Thompson, general counsel of the mHealth Regulatory Coalition. "Or a home health monitor fails to notify a nurse when a patient's health is deteriorating?" …
Discussions about how the FDA should regulate health IT began in earnest in 2010, when senior officials at the FDA's Center for Devices and Radiological Health produced a confidential report of at least 6 deaths and 44 injuries related to health IT errors in two years. Those incidents occurred before the explosion of medical apps, and arose more from problems related to the shift to electronic medical records.
The FDA up to now has not required health IT vendors to report failures, the way drugmakers and standard medical device makers must. And without that requirement, it may be hard to get a good assessment of any problems.
"When you get into the more serious apps, people rely on them for their health," Thompson said. "If they rely on them instead of engaging some other part of the health care system, there's a risk."
It's the risk, he said, of bad information.
