The FDA announced today a new policy that permits expanded use of connected, non-invasive remote vital sign monitors until the end of the COVID-19 public health emergency.
The agency is relaxing its prior guidance so that healthcare teams can monitor their patients outside of the hospital with certain devices that were previously cleared by the FDA, thereby freeing up space for the high volume patients who are in need of care due to the novel coronavirus.
The agency said that it would "not intend to object to limited modification to the indications, claims, functionality or hardware or software" of these devices. Examples of this would include monitoring for COVID-19 itself or for co-existing conditions, as well as hardware and software modifications that increase remote monitoring capability. In addition, the expanded use extends to some software products that pair with the monitors and use algorithms to provide clinical decision support (CDS) insights.
The applicable connected non-invasive monitors listed in the emergency guidance are: clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximeters, respiratory rate or breathing frequency monitors, non-invasive blood pressure monitors and electronic stethoscopes.
WHY IT MATTERS
The FDA's latest decision comes at a time when the healthcare industry is being strained to its limits by a pandemic taking the world's infrastructure by storm.
“Allowing these devices to be used remotely can help health care providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,” FDA Principal Deputy Commissioner Dr. Amy Abernethy said in a statement. "During this public health emergency, it is imperative that the FDA provide regulatory relief and adapt as the situation warrants to act upon measures to save lives.”
The relaxing of regulatory red tape was applauded by Epstein Becker & Green's Bradley Merrill Thompson, who counsels on regulation of medical devices and related products. In reviewing the temporary policy, he said that the language will likely extend care capacity of legitimate and appropriate devices without giving too much leeway.
"This is a highly intelligent approach," Thompson told MobiHealthNews in an email. "Thinking about how to approach these issues, one of the concerns I had is watching the news with regard to all of the fraud and disreputable people out there trying to sell things that don’t work. FDA has to be mindful of that. Not all people are good.
"The nice thing about FDA’s approach is it is very practical and doesn’t open the floodgates wide to potential fraudsters. It basically says the companies need to carefully think through how their products can be used, and make limited suggestions of labeling, but not go too far where they might actually create more harm than good. At first read, the dividing lines between what’s permitted and what’s not permitted seem reasonably clear and helpful. I’m sure that as we progress there will be questions, but I think this is a hugely positive step."
THE LARGER TREND
The FDA is just one executive branch agency relaxing its digital health restrictions during these trying times. The last week alone saw the Centers for Medicare and Medicaid Services expand its Medicare telehealth coverage, while the HHS Office for Civil Rights said that it would use discretion when enforcing HIPAA-compliance for telehealth communication tools.
Also of note is how this temporary policy relates to prior draft guidance involving CDS software. For Thompson and other industry figures who weren't 100% onboard with the earlier proposal's requirements, the temporary policy's relaxed requirements are a temporary glimpse at their preferred implementation.
What FDA is doing in this emergency guidance is basically waving that September 2019 objection that CDS can only escape FDA regulation if it is both low risk and transparent. FDA is saying in this context, even though the risk is arguably higher, they will accept transparency," he said. "I don't know if FDA will give up on the broader position expressed in September, but I'm delighted that they are being practical here."