Regulatory Relief for AI-in-Healthcare Products

1. Introduction of Your Company

  1. What is your company’s profile and mission?
  2. When was your company founded? Where are you based?
  3. Do you have a track record of successful AI products and/or healthcare products?

2. Description of Proposed Product

  1. Pitch your proposed product.
  2. Who does your product serve?
  3. Which vulnerable populations (if any) can use your product (e.g., minors, pregnant or breastfeeding patients, non-English speakers, underinsured, etc.)?
  4. Walk us through a high-level end-to-end customer experience with your product.
  5. Articulate possible benefits to Utahns. What are the expected effects on healthcare costs, healthcare access, and healthcare equity (if any)?

3. Feasibility

  1. Describe the resources your organization possesses that will enable this product to be successful (e.g., expertise, funding, liability insurance, stakeholder networks).
  2. Provide any evidence the product will work as intended (e.g., academic literature, pre-deployment testing, operation of similar products, FDA clearance).

4. Regulatory Relief Request

  1. What Utah statutes are causing friction for your product? (If you cannot identify specific statutes, describe potential legal/regulatory obstacles.)
  2. What relief would you like from these legal/regulatory obstacles (e.g., waiver, cure period, clear interpretation)?

5. Outline of Pilot

  1. Outline the structure of the proposed product pilot, including pilot duration and timeline, phase of deployment (if any), and benchmark requirements for phase progression.
  2. Outline risk management throughout the pilot, including monitored KPIs, monitoring for adverse events, and protocol for phase rollback in the event of degrading KPIs or adverse events.
  3. Outline plans for sharing data on product safety, efficacy, and value with OAIP and other stakeholders (e.g., the public, researchers, auditors, FDA).

6. Confidentiality Claims (Optional)

  1. If any requests in this document require the disclosure of either (1) trade secrets or (2) commercial information that, if exposed, could lead to unfair competitive injury, please provide: (i) a written claim of business confidentiality; and (ii) a concise statement of reasons supporting the claim of business confidentiality.
  2. Providing a written claim of confidentiality with concise reasons supporting the claim will allow the office to designate those records as “protected” under GRAMA (See Utah Code 63G-2-305(1)-(2) and 63G-2-309(1)).