A BILL to amend the Code of Virginia by adding in Title 32.1 a chapter numbered 21, consisting of sections numbered 32.1-376 through 32.1-383, relating to Health Care Learning Lab and Regulatory Improvement Program established.
HB146 creates a new chapter in Title 32.1 establishing the Health Care Learning Lab and Regulatory Improvement Program. The program would let approved participants test innovative health care products, services, and delivery methods in Virginia on a limited basis without first obtaining the licenses or other state authorizations that would normally be required. The bill is aimed at encouraging experimentation with technologies and business models such as blockchain, artificial intelligence, telehealth, and telemedicine, and it authorizes the Department of Health to host or participate in hackathons to support development of new ideas.
To participate, an applicant must submit a detailed application showing that it is subject to Virginia jurisdiction, has a testing location, has a plan and resources to conduct the test, and can protect consumers if the test fails. The application must identify the laws and requirements the applicant wants waived, explain the consumer benefits and risks, describe the testing plan, and show that the testing will occur in diverse communities or in areas with lower household income. The Commissioner may approve all, some, or none of the requested waivers, and may also waive additional requirements if needed for testing. Approved testing periods generally last 24 months, with possible extension up to 30 months total, and the program expires July 1, 2030.
The bill also sets out consumer protections and oversight requirements. Participants must make clear disclosures that the service is part of a temporary test, may not work as intended, is not endorsed by the Commonwealth, and can be complained about to the Department. The Department may inspect, investigate, suspend, or revoke participation if the program poses a danger to public health, safety, or welfare, or if the participant is not acting in good faith. Participants must keep records, submit quarterly reports, and report failures or complaints, while the Commissioner must provide annual reports to legislative committee chairs.
HB146 would affect state law by creating a regulatory sandbox within Virginia health law and temporarily suspending certain licensing and authorization requirements for approved participants. It expressly does not waive licensure, certification, or registration requirements for health care providers with prescriptive authority, and it does not waive certificate of public need requirements. It also deems participants to have appropriate state authorization for certain federal-law purposes during the testing period, while preserving liability and consumer complaint processes.
The overall sentiment reflected by the bill text is pro-innovation and pro-experimentation, with a strong emphasis on consumer safeguards and regulatory oversight. Because there are no committee transcripts or recorded votes, there is no documented public debate in the provided materials. The main points of potential contention are likely to be the breadth of licensing waivers, the Commissioner’s authority to waive additional requirements, the risk of consumer harm during testing, and whether the program could bypass important health care regulations or create uneven treatment among market participants.
HB146 would add a new regulatory framework to Title 32.1 of the Code of Virginia, creating a health care sandbox program that allows limited testing of innovative products and services under state supervision. It would temporarily waive selected licensing, authorization, and related regulatory requirements for approved participants, while preserving certain core health care rules such as prescriptive-authority licensure and certificate of public need requirements. The bill also imposes reporting, disclosure, recordkeeping, and enforcement duties on participants and the Department of Health, and it sunsets the program on July 1, 2030.
The bill appears generally favorable toward innovation in health care delivery, with the structure of the proposal reflecting support for new technologies and business models alongside consumer protections. No committee discussion or vote history was provided, so there is no recorded opposition or endorsement in the supplied materials. Based on the text alone, the measure seems designed to balance experimentation with oversight, suggesting a cautious but supportive policy approach.
The likely areas of contention are the scope of regulatory waivers, the Commissioner’s discretion to approve partial or additional waivers, and the possibility that participants could operate without standard licensure requirements during the testing period. Critics may also focus on consumer risk, liability exposure, and whether the program could undermine existing health care oversight or create unfair advantages for selected entrants. Supporters would likely emphasize the program’s safeguards, limited duration, and requirement that testing occur with consumer disclosures and Department monitoring.