Many states have abortion restrictions on the books after the Supreme Court overturned Roe v. Wade. The legal landscape increases the likelihood that patient's health data could be disclosed in ways that erode trust in providers or prevent patients from seeking care or sharing information with clinicians, regulators said in the rule.
The Health Data, Technology and Interoperability: Protecting Care Access Final Rule, or HTI-3, comes less than a week after the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology finalized another interoperability rule. Last week's regulation was focused on provisions related to the Trusted Exchange Framework and Common Agreement, a governance framework for data exchange.
Both new regulations stem from a sweeping proposal first announced by the agency this summer. The rules don't include some sections originally included in the proposed regulation, like first-of-their-kind criteria for software used by public health agencies and payers to be certified by the ASTP/ONC.
However, more interoperability regulations are in progress, according to the federal government's unified agenda. An ASTP/ONC spokesperson told Healthcare Dive last week that the scope of the original proposed rule and the number of comments made it challenging to finalize the proposed regulation in its entirety quickly.
The HTI-3 final rule focuses on information blocking exceptions, particularly those related to reproductive healthcare. Providers, IT developers and information sharing exchanges are typically barred from blocking the flow of electronic health data, but regulators can create exceptions through rulemaking.
The regulation permits actors to restrict data sharing if they have a good faith belief that people seeking, obtaining, providing or facilitating reproductive healthcare could face legal jeopardy if that information was shared.
The latest rule comes as some experts and policymakers have raised concerns that health data could be used to prosecute women and clinicians in states that have largely banned abortion or added new restrictions.
Patients are increasingly traveling to states where the procedure is legal, according to the Guttmacher Institute. About 92,100 people traveled out of state for an abortion in the first six months of 2023, compared to 40,600 in the first six months of 2020.
The Biden administration has already taken other steps in a bid to strengthen privacy protections for patients seeking reproductive healthcare.
This spring, the HHS' Office for Civil Rights finalized a rule that prohibits HIPAA-covered entities from disclosing protected health information for investigations, or to impose legal liability if the care was legal in the state it was received.