The U.S. Food and Drug Agency is dropping plans to regulate medical device data systems and certain medical image transfer systems, saying the risks are too low to warrant federal scrutiny and could instead hinder innovation.
And while mHealth advocates are generally appreciative that federal regulators aren't going to be heavy-handed in governing the industry, some are worried that they might be going too far in the other direction.
The FDA defines MDDS as "hardware or software products that transfer, store, convert formats and display medical device data. A MDDS does not modify the data, and it does not control the functions or parameters of any connected medical device. MDDS are not intended to be used in connection with active patient monitoring."
In its nine-page draft guidance document, released on June 20, the agency says the mHealth ecosystem "requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology." It pointed out that just three years ago, the agency changed the classification of MDDS from Class III (high-risk) to Class I (low-risk).
"Since down-classifying MDDS, the FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public," the FDA wrote. "Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices and medical image communications devices."
Bradley Merrill Thompson, an attorney with the Washington D.C. law firm of Epstein Becker Green who advises the mHealth Regulatory Coalition, told mHealth News the guidance "is big" because it clarifies a long-standing issue among mHealth developers: What will be regulated, as in medical devices, and what won't, as in electronic health records.
"I have to admit … I'm pretty bothered that they are choosing to do this through a guidance document only," he said. "That's the wrong way to regulate. There is a regulation on the books that needs to be changed and, indeed, in FDASIA section 608 Congress just gave FDA an expedited way to update classification regulations. On the one hand, I appreciate the desire for speed, but I hope they update the classification regulations soon."
Laurie A. Clarke, a partner in the Washington firm of Jones Day who focuses on FDA regulations, said the new guidance document offers "a very narrow definition" of MDDS. She feels the FDA is creating a "most basic" definition of MDDS that mHealth developers can use to measure their product against, and in doing so is fostering innovation.
"Companies within this space now have an incentive to try and fit their products into this MDDS definition," she added.
Clarke said patient advocates might be concerned that the FDA is stepping back too far. She pointed out that there have been some recalls of MDDS products over the past few years, mostly for communication or transmission issues. She also wondered if the FDA might be issuing this guidance as a pre-emptive strike – in essence, showing that it's serious about mHealth regulation before the ONC or Congress decides to step in and assume more control.
In a blog accompanying the release of the guidance document, FDA Senior Policy Advisor Bakul Patel said public comments on FDA regulations to date, particularly the FDASIA report, indicate the industry supports a "risk-based regulatory framework for health IT that promotes innovation, protects patient safety and avoids regulatory duplication." Patel said the FDA is committed to focusing on high-risk medical devices that need close oversight, while those with less risk can be monitored by the ONC and the Department of Health and Human Services.
"This guidance is consistent with the notion that FDA is getting out of the broad health IT management sphere, and leaving that to ONC," Thompson pointed out. "I think they decided that the risk simply isn't there for FDA style controls, and that ONC voluntary standards are more consistent with the risk level."
