March 27, 2026
8 min read
Key takeaways:
- One presentation at this year’s vMed conference highlighted updated federal policies in the digital health space.
- The expert broke down the implications for providers, patients and businesses.
LOS ANGELES — It is important for primary care providers to understand new federal regulations surrounding wearables, wellness and clinical decision support, especially because it will impact reimbursement, according to a speaker here.
Aubrey Shick, a former official in the FDA’s Digital Health Center of Excellence, offered a presentation on FDA’s January 2026 updates, and how they “change the game” for wearables, clinical decision support and wellness at Cedars-Sinai’s eighth annual iteration of its Virtual Medicine Conference, vMed.
Healio spoke with Shick to learn more about the changes, the real-world impact, what PCPs need to know and more.
Healio: What exactly were the updates to digital health guidance that FDA released on Jan. 6, and then revised on Jan. 29?
Shick: Just to be clear, this isn’t exhaustive — these are multi-page policies.
There were two digital health guidances that were updated Jan. 6, and that was the clinical decision support guidance and the general wellness guidance. The clinical decision support guidance was updated again on Jan. 29. These are really interesting times. I was previously a senior digital health advisor on the policy team in the Digital Health Center of Excellence at the FDA. And, typically, when guidance like these are updated, they’re usually updated in a draft format. There’s an opportunity for public comment. There’s a very specific process. This year, they were announced at Consumer Electronics Show, which was really unique and exciting.
So, what changed? We had the commissioner on stage saying that, “we need regulatory to be working at Silicon Valley speeds.”
A significant update is that there’s now an opportunity for clinical decision support software to have a single recommendation. Before, any clinical decision support that had a single recommendation was sort of default regulated. If something came across my desk when I was at FDA and the output was a single recommendation, it immediately failed the non-device criteria, which meant you needed authorization from FDA before you could bring it to market. Now it’s been clarified that in scenarios where it is not clinically relevant, it is possible to have a singular recommendation. But this is much trickier than I think folks in the wellness and wearables and digital health space may realize. Let me put it this way, if any of my clients or anyone working with me is like, “Hey, we’re trying to put a clinical decision support software out, and we don’t want it to be regulated by FDA,” I would say, “All right, you’re going to be in a much better situation if the output of your software is providing recommendations with an ‘s’ instead of being prescriptive, because a singular recommendation still is going to require a lot of justification that no other output is clinically relevant, and it’s very possible that FDA may ask you to come in for a cue submission meeting to kind of lift up the hood — show us how your system works.”
One of the things that was said is that clinical decision support software was being made artificially dumber and harder to use by health care providers because of some of these policies. So, the intent was for the policy to be updated specifically for this purpose. Another thing is a little more clarity around health care professionals’ ability to independently review the basis of a recommendation. Part of clinical decision support is that it’s not replacing the judgment of a health care professional; it is kind of speeding up the organization and presentation of the information that the health care professional needs to make decisions. There has also been some additional clarity around who the user is. So, something that’s really important for folks to know about clinical decision support — this was already clear — is that something cannot be non-device clinical decision support unless it’s intended to be used by a health care professional. If you’re creating clinical decision support intended for use by a caregiver or a patient, the non-device policy isn’t applicable.
Then, there were also some changes to the general wellness policy for low-risk devices. There’s a little more of a nuance that was added around wearable devices sensing information and notifications. The thing is, a lot of companies think that if they just say, “we’re a wellness product,” that then it’s like that scene in “Star Wars” where Obi-Wan says, “These are not the droids you’re looking for,” and the stormtroopers walk away. That’s what people think. But actually, you can’t just say we’re general wellness and FDA walks away. If you were doing things that are clearly regulated device functions, those policies may not be appropriate a lot of the time. The device software function policy makes a lot more sense.
In a lot of ways, the roots of these policies are really the same. The biggest thing that’s happened is that there are more examples in these policies to really help innovators know when their product is aligned with something that’s a focus of oversight vs. something that isn’t.
Healio: Is this positive or negative? What will the real-world impact be here?
Shick: The positive change in terms of market access here is that we’ve widened the scope of software in the digital health space that’s able to go to market without requiring pre-market oversight and authorization from FDA. From the point of view of an innovator who’s looking to figure out product market fit, get people using a product, develop functionality with the intention of building out more robust use cases as you go, this is really exciting. There’s a faster path to market from the point of view of somebody who really wants to be reimbursed for the products you are creating.
The number of things that are clearly reimbursed has narrowed a little bit. That means if your client or if your customer is, let’s say, an employer or a health plan, and you’re doing a [business to business] kind of play, that’s one thing. But if you were planning on payers or patients, coverage providers to be covering some of this, it’s extra tricky. FDA has made clear that for products that did receive authorization for being “device clinical decision support,” that even if they are no longer “device clinical decision support” under the new policy, their authorization still holds. But from the point of view of that company rolling out future products and continuing to be covered as they are now, that’s a little fuzzy. Why would a payer continue paying for them as a medical device if they’re no longer requiring regulation? That’s a kind of sticky thing there. So, I’d say it’s great for innovation, but the long-term viability of different businesses is going to require a little more creativity, a different strategy.
Healio: What do those changes mean for health care providers specifically?
Shick: One of the problems that we see in the digital health space is health care professionals don’t necessarily know when to trust digital health products, and that doesn’t matter whether it’s virtual medicine, digital therapeutics, wearables-based — it’s just really hard for folks to know, when is this safe and effective? Which patient population does this work for? And part of FDA device authorization, you have the intended use, just like any other medical device or drug that you may use in your practice as part of patient care. You have that authorization to look at, to understand how this is substantially equivalent or safe and effective, and you can rely on that. We’re seeing different opportunities for third party organizations to be doing that sort of thing but, ultimately, if you have fewer things that are receiving oversight from FDA, it’s harder to know what you can trust and not trust.
And then, of course, health care professionals are reimbursed for the time they spend doing things, whether that’s part of remote patient monitoring or various other elements, and reimbursement is very, very hard in the digital health space. But there are different opportunities for waivers and other things that much of the time are tied to whether or not the product meets the definition of a device. When you have these things in enforcement discretion, that the definition of enforcement discretion under the device software policy is specifically something for which FDA does not intend to determine whether or not it is a device, or determine whether or not it’s in compliance with regulations under the Federal Food, Drug and Cosmetic Act. So, it may or may not be a device. Technically, the definition of non-device clinical decision support is that it is not a device, therefore it’s just not regulated. That means all of the good manufacturing practices, all kinds of things that you would typically have in place for safety and product lifecycle management do not need to be in place.
Healio: Does this impact patients? Is there anything PCPs should be telling their patients about these changes?
Shick: I would say this definitely impacts patients from the point of view of, it’s a lot easier for more folks to have things out there and be marketing it. From the point of view of clinical decision support — the way the policy is written — clinical decision support should only be facing health care professionals. And this could be a clinical decision support software function embedded within the electronic medical records.
I’ve seen clinical decision support to help people manage aesthetic procedures, like related to Botox or fillers. I’ve seen clinical decision support around oncology care. Clinical decision support can affect a lot of things, and so from the point of view of a patient, non-authorized clinical decision support means that your health care professional has a tool to help them make decisions more quickly, but ultimately their clinical judgment is how the risk is managed. They are still responsible, it’s just there’s a little bit less oversight than there was at another point, making sure that this health care professional has everything they need, so that they don’t rely on the output of this software for the basis of their decision.
It would be great if health care professionals would communicate to patients when they are using a clinical decision support software, like, “Oh, hey, I looked at this. Having said that, this is within the practice of medicine.” Health care professionals use all sorts of tools, it would be absurd to disclose all of these to your patients. If there was one that was maybe particularly integral to the clinical workflow and process, that could be something to disclose. That’s something that really is just from a public service announcement — things that I would like patients in America to know. Also, we’re now at a time where the U.S. has really adjusted oversight and enforcement in the digital health space in a way that is very clearly prioritizing innovation, in ways that, say, you wouldn’t necessarily see in the EU or UK.
Healio: What is the take-home message here?
Shick: The first thing I would want people to get out of this is that there’s more opportunity for finding product market fit and early access to customers, so long as you are aligning your marketing and your user interface with those policies. However, at the same time, you need to be extra savvy about what your business and payment or reimbursement strategy is, because that’s now more challenging than it was before.
I want folks to be excited, but cautiously optimistic. The big thing here is that folks really need to be aligning with these policies and not just taking some of the rhetoric and the promotional stuff around this — like “moving at Silicon Valley speed.” Getting out of the way, being more user friendly — all this sounds great, but the policy is still the policy and you still need to align with it. I’m still helping clients with allegations and compliance within these policies all the time, and it can be done. What I tell people is you can have the exact same software functionality, the exact same code, and based on how you market it and how you describe your intended use and your user interface, it could be non-device, general wellness, enforcement, discretion or fully regulated, just by changing words.
For more information:
Aubrey Shick can be reached on LinkedIn @AubreyShick.
Sources/Disclosures
Source:
Healio Interviews
References:
Disclosures: Shick reports no relevant financial disclosures.
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