The Washington Post reports on the issue of patient privacy and mobile applications related to medical data:
As smartphone users have grown more comfortable forking over information about their bank accounts and physical whereabouts to mobile applications, a growing group of app developers are betting health-related data will be next. [...]
Applications are being built to assist physicians at a patient’s bedside or help remotely monitor chronic conditions, but remain somewhat limited by concerns about their ability to ensure patient safety and privacy.
That’s caught the eye of federal regulators. The Food and Drug Administration will likely finalize its first-ever guidance on mobile health applications later this year, giving the agency at least some oversight of mobile products that replace or complement other medical devices, such as a stethoscope or EKG machine.
Bakul Patel, a policy adviser who helped craft the guidelines, said the pace of innovation for mobile tends to be faster than that of the medical devices and software the agency has had to monitor to date. [...]
Mohamad Makhzoumi, a partner at investment firm New Enterprise Associates, said health care start-ups are wary of pending regulatory changes, but added that federal oversight has long created an inherent degree of uncertainty in the health care industry.
“It hasn’t slowed down the pace of company formation or capital raise, but it’s something that is difficult to nearly impossible to handicap,” he said. “So what you’re seeing today is people willing to take the risk given that the opportunity is so large.”
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