I wonder if this might become a monthly feature? After all, the ATA webinar I’m talking about was titled: This Month in Telemedicine.
I won’t go into great detail about legislation and such. For that, I highly recommend the replay which can be found here.
The three items I’d like to look at are:
1. The FDA has released draft guidance for devices for review and comment. It can be found here. What’s notable is that previously the FDA only wanted to downclass a broad selection of devices and software. The FDA now believes the devices and software are of low enough risk to just remove requirements outright (or at least not enforce compliance). Take a look at the first two paragraphs from the introduction of the guidance:
“The Food and Drug Administration (FDA) recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software that transfer, store, convert formats, and display medical device data or medical imaging data.
“The FDA is issuing this draft guidance document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.”
2. Nearly every medical institution in the US is using some form of telemedicine, but many medical boards are not aware of it. That’s a paraphrase from Mr. Linkous, CEO of the ATA, who was moderating the call, and is anecdotal to him. He said that his discussions with medical boards has shown him that they tend to equate telemedicine only with video consultations, and that educating medical boards is an important function of the ATA. (I would assume it is for all of us involved in telemedicine.) Additionally, Gary Capistrant, Sr. Dir. of Public Policy for the ATA, mentioned that many licensing boards are likewise unaware of just how much and what types of telemedicine are being used within their regions.
3. Lastly, and something I actually assume we all knew: The relationship between the AMA and ATA is thawing and they are now even working together on several projects. This has actually been coming out in various news outlets since the changing of the guard over at the AMA and the new guard’s overt statements of support for telemedicine/telehealth. Still, when taken along with the FDA’s new guidance, I think this bodes very well for telemedicine able to make even more inroads to more traditionally conservative healthcare providers and also further push insurance to take more action in creating payment structures for telemedicine-provided care.
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