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While vendors of trendy mobile personal health apps and other medical data device systems may be hailing the U.S....
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Food and Drug Administration draft guidance that leave mobile health apps largely unregulated, healthcare providers will likely be advised to tread carefully to ensure safety and quality.
The FDA indicated that it will take a step back from mobile device data systems (MDDS) potential oversight as Apple Inc., Google Inc., WebMD Health Corp. and several other big players have announced initiatives for consumers to track personal health data on handheld devices and eventually transmit it to physicians. Apple and Epic Systems Corp. have also formed an alliance to move smartphone apps into the provider sphere.
Rick Hampton, wireless communications manager for Partners HealthCare in Boston and a nationally recognized authority on MDDS, warned providers and consumers to use extra diligence in the expected absence of FDA oversight.
"Inside the industry this is a very big thing. It has both good ramifications and bad ramifications," Hampton said. "On face value it spurs innovation, but on the downside it creates an extremely low barrier for creation of safe medical devices. There are no checks and balances on people creating medical devices that are safe."
If consumers and healthcare providers don't scientifically vet their MDDS, including ones using mobile devices, Hampton said "it's not going to work well for someone."
Rick Hamptonwireless communications manager, Partners HealthCare
"I just hope it's not my family member," he said.
Two years after it down-classified MDDS from Class III high-risk to Class I low-risk, on June 20 the agency clarified in a set of nonbinding guidance proposals that it does not intend to enforce compliance with regulatory controls on MDDS.
That includes relieving vendors of regulatory requirements such as registering and listing with the FDA, premarket review, reporting adverse events and implementing quality systems regulation.
The seven pages of rule amendments -- mostly consisting of deletions of language applying enforcement power over MDDS -- were accompanied by an authoritative blog post by FDA policymaker Bakul Patel.
"Today, given the low level of patient risk, we are proposing a compliance policy under which medical device data systems should see their burdens reduced," Patel wrote. "This allows developers of medical device data systems to focus on making these products better able to operate amongst various devices and technology stems -- resulting in stronger products."
The draft update came with a 60-day comment period. After that, "the FDA intends to finalize this guidance after analyzing the comments," Jennifer Rodriguez, an FDA spokeswoman, said in an emailed statement. Industry observers say it's all but a done deal.
Even though critics such as Hampton see the FDA gesture in some ways as a nod to big vendors, others who track the health IT industry take a more benign view.
For example, the FDA's loosening of its enforcement mandate appears to apply mainly to software and the software interfaces between devices such as traditional medical instruments including glucometers and blood pressure monitoring systems.
Those hardware devices will continue to be tightly regulated, with a structured review and approval process, noted Chris McCord, managing partner of Healthcare Growth Partners, an Elmhurst, Illinois, healthcare investment and consulting shop.
"If it's going to be used in clinical decision support and not just in an EMR, that still falls under the [purview] of the FDA," McCord said.
McCord said in light of FDA's newly smaller role in this arena, he'd advise MDDS developers to take the further step of submitting products to stringent third-party review. And he echoed some of Hampton's worries as well, saying, "If it's safety and quality of data, that's potentially an issue."
As for the thorny question of what constitutes a device, where it ends and where the data system starts, the FDA's Rodriguez suggested that smartphones, for example, will be exempt.
"Doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient's health. Often this data comes from an app," Rodriguez said. She pointed to the low-risk profile of MDDS, the need to encourage more innovation in digital health and the role mobile health apps play in digital health as factors in the FDA's decision. The policy, she said, "should result in a reduced burden for manufacturers of these devices."
Meanwhile, Hampton, who has decades of experience in the bioengineering realm connecting devices to patients and data to physicians, maintained that FDA oversight is good for patients and that Partners' experience with FDA approval for MDDS of its own design has been positive. For instance, one vital-signs monitoring device system for which Partners wrote its own software interface connector, took about half of one IT employee's time for a year to secure approval, he said.
"Everyone says the regs are terribly hard to comply with," Hampton said. But they're not, he stated.
"Anyone can write an app whether they know what they're doing under these circumstances and without vetting it for accuracy," Hampton said. "Any consumer who uses it for serious healthcare concerns is foolish and any doctor who uses it for diagnosis and treatment is even more even foolish."
"Google has a self-driving car, but would you hop into it and drive away without inspecting it first?" Hampton said, referring to one of the search-engine behemoth's recently hyped tech projects. "The problem is the consumer doesn't understand any of this and the currency here is consumers' health."
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