summary
Introduced
11/19/2024
11/19/2024
In Committee
11/19/2024
11/19/2024
Crossed Over
Passed
Dead
02/22/2025
02/22/2025
Introduced Session
2025 Regular Session
Bill Summary
Health Care Regulatory Sandbox Program established. Requires the Department of Health to establish the Health Care Regulatory Sandbox Program to enable a person to obtain limited access to the market in the Commonwealth to temporarily test an innovative health care product or service on a limited basis without otherwise being licensed or authorized to act under the laws of the Commonwealth. Under the Program, an applicant requests the waiver of certain laws, regulations, or other requirements for a 24-month testing period, with an option to request an additional six-month testing period. The bill provides application requirements, consumer protections, procedures for exiting the Program or requesting an extension, and recordkeeping and reporting requirements. The bill requires the Department of Health to provide an annual report to the Chairs of the House Committee on Health and Human Services and the Senate Committee on Education and Health that provides information regarding each Program participant and recommendations regarding the effectiveness of the Program. The bill directs the Board of Health to adopt emergency regulations to implement the provisions of the bill and has an expiration date of July 1, 2030.
AI Summary
This bill establishes a Health Care Regulatory Sandbox Program within the Virginia Department of Health to foster innovation in healthcare services and products. The program allows participants to test innovative healthcare approaches or delivery methods (such as blockchain technology, artificial intelligence, or telehealth) for up to 24 months without obtaining traditional state licensing, with a possible six-month extension. Applicants must submit detailed applications demonstrating their plan, resources, potential consumer benefits, and risks, and must obtain Department of Health approval. Participants are required to provide clear disclosures to consumers about the experimental nature of their services, including potential risks and the temporary status of the offering. The program includes robust consumer protections, such as mandatory information disclosures, complaint mechanisms, and the Department's ability to suspend or revoke participation if public safety is at risk. Participants must maintain detailed records and provide quarterly reports, and the Department will submit an annual report to legislative committees evaluating the program's effectiveness. The program is set to expire on July 1, 2030, and is designed to help innovative healthcare solutions gain market access while maintaining consumer safeguards.
Committee Categories
Health and Social Services
Sponsors (1)
Last Action
Failed to report from Health and Human Services with substitute (9-Y 12-N) (on 01/30/2025)
Official Document
bill text
bill summary
Loading...
bill summary
Loading...
bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://lis.virginia.gov/bill-details/20251/HB1555 |
| BillText | https://lis.virginia.gov/bill-details/20251/HB1555/text/HB1555HC2 |
| Fiscal Note/Analysis - Fiscal Impact Statement from Department of Planning and Budget (HB1555) | https://lis.blob.core.windows.net/files/1026204.PDF |
| BillText | https://lis.virginia.gov/bill-details/20251/HB1555/text/HB1555HC1 |
| BillText | https://lis.virginia.gov/bill-details/20251/HB1555/text/HB1555 |
Loading...