Every AI rule that hits healthcare — scored against your product.
AI medical scribes, clinical-decision support, hospital chatbots, billing-code suggesters. The FDA, FTC, EU AI Act, and HIPAA-adjacent rules pile up fast. We monitor them so you don't have to.
Why Healthcare AI founders use RegImpact
Healthcare AI is the highest-stakes regulatory segment in the entire industry. The FDA treats some AI tools as medical devices and others as wellness software — the line moves quarterly. The EU AI Act classifies most clinical-decision AI as "high-risk," with mandatory technical files, human oversight, and ongoing monitoring obligations.
For an indie founder, keeping up with this manually is a part-time job. A weekly digest of "FDA opened consultation on X" doesn't tell you whether X applies to your specific product. RegImpact does — every new rule gets scored 1-10 against your actual product description, with the action items already drafted.
What you're actually up against
- FDA classification rules change quarterly — easy to drift from "wellness app" to "medical device" without realizing it
- EU AI Act high-risk obligations apply if any of your users are in the EU, even if your company is US-only
- HIPAA + state privacy laws (TX, IL biometric) layer on top of AI-specific rules
- A single missed enforcement action can mean a six-figure consent decree
Score your Healthcare AI product
We've pre-filled a typical healthcare ai product description. Edit it to match yours, drop in your email, and you'll get the top 3 most-relevant regulations scored 1-10 against your product (plus the rest emailed and behind the paywall).
AI medical scribe that listens to doctor-patient visits, generates structured clinical notes, and suggests ICD-10 / CPT billing codes. Used by primary care and specialty clinics in the US.
We'll send your scan results plus 2 short followups. No spam, unsubscribe anytime.
Click Run to score this product profile against the most recent AI regulations in our database. 60 seconds.
Recent rules we're tracking (169 total)
A snapshot of the highest-relevance AI regulations in our database right now. Click into any rule for the plain-English explainer, or run the scan above to see which ones actually apply to your product.
- federal register
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information
The Food and Drug Administration (FDA or the Agency) is issuing this request for information to solicit input on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision- making in early phase clinical trials. Ear
- fcc
Implications of Artificial Intelligence Technologies on Protecting Consumers From Unwanted Robocalls and Robotexts
In this document, the Federal Communications Commission (Commission or FCC) proposes steps to protect consumers from the abuse of Artificial Intelligence (AI) in robocalls alongside actions that clear the path for positive uses of AI, including its use to improve access to the telephone network for
- fcc
Disclosure and Transparency of Artificial Intelligence-Generated Content in Political Advertisements
In this document, the Federal Communications Commission (Commission or FCC) initiates a proceeding to provide greater transparency regarding the use of artificial intelligence-generated content in political advertising. Specifically, the Commission proposes to require radio and television broadcast
- fcc
Open Commission Meeting Thursday, August 3, 2023
The Commission will consider a Notice of Inquiry that would initiate a technical inquiry into how to obtain more sophisticated knowledge of real-time non- Federal spectrum usage-- and how the Commission could take advantage of modern capabilities for doing so in a cost- effective, accurate, scalable
- eu ai act
Overview of Guidelines for GPAI Models
On 18 July 2025, the European Commission published draft Guidelines clarifying key provisions of the EU AI Act applicable to General Purpose AI (GPAI) models. The Guidelines provide interpretive guidance on the definition and scope of GPAI models, related lifecycle obligations, systemic risk criteri
- eu ai act
Providers of General-Purpose AI Models — What We Know About Who Will Qualify
This content is outdated – Draft guidelines have now been published by the AI Office, which you can learn more about here. On 22 April 2025, the AI Office published preliminary guidelines clarifying the scope of the obligations for providers of GPAI models. These outline seven topics that are expect
- fcc
Open Commission Meeting Wednesday, August 07, 2024
The Commission will consider a Report and Order to establish a Missing and Endangered Persons event code that will provide law enforcement, EAS Participants, and WEA providers with a means to quickly disseminate information pertaining to missing and endangered persons cases. 2.................. Cons
- eu ai act
Why work at the EU AI Office?
It’s probably not for everyone, but there are a lot of great reasons to consider, including the potential to have an impact on AI governance worldwide, leveraging the first-mover advantage, and more.
FAQ
- My product is a wellness app, not a medical device. Does this still apply to me?
- Probably yes. The FDA's line between wellness software and medical device hinges on intended use claims. If your marketing copy implies clinical decision support — even for "informational purposes" — you're likely on the medical-device side. RegImpact scores each FDA guidance against your actual product description so you find out before an enforcement letter does.
- I don't serve EU customers. Does the EU AI Act still apply?
- Probably no — but the EU AI Act applies the moment any of your users is in the EU, including unintentionally. If your product has a public sign-up and runs on Stripe, you have EU users by default unless you geofence. We flag every EU AI Act guideline that affects healthcare AI so you can decide whether to scope in or scope out.
- What about state-level laws like Texas TBPHA or Illinois BIPA?
- We track CA, CO, TX, and IL state legislation that touches AI/biometrics. Texas TBPHA (covered: voice cloning, deepfake medical content) and Illinois BIPA (covered: any biometric ID) absolutely apply to healthcare AI. Each gets its own impact score against your product.
- How is this different from hiring a healthcare compliance lawyer?
- Different price point and different cadence. A lawyer reviews specific actions you're about to take. We continuously monitor everything that's changing and tell you what merits a lawyer's time. Use both. Most of our customers are early-stage and use us instead of a retained compliance attorney until they raise.