ASTP finalizes information blocking exception for reproductive health

Dive Temporary:

Regulators have up to date guidelines that bar blocking the move of digital well being data, together with a brand new exemption that goals to protect entry to reproductive healthcare. 
A brand new ultimate rule permits suppliers, well being IT builders or knowledge exchanges to limit data sharing when there’s threat it might expose sufferers or clinicians to authorized fallout from in search of reproductive healthcare, corresponding to abortion care.
Many states have abortion restrictions on the books after the Supreme Courtroom overturned Roe v. Wade. The authorized panorama will increase the chance that affected person’s well being knowledge may very well be disclosed in ways in which erode belief in suppliers or stop sufferers from in search of care or sharing data with clinicians, regulators mentioned within the rule.

Dive Perception:

The Well being Knowledge, Expertise and Interoperability: Defending Care Entry Ultimate Rule, or HTI-3, comes lower than every week after the Assistant Secretary for Expertise Coverage/Workplace of the Nationwide Coordinator for Well being Info Expertise finalized one other interoperability rule. Final week’s regulation was centered on provisions associated to the Trusted Trade Framework and Widespread Settlement, a governance framework for knowledge change.

Each new rules stem from a sweeping proposal first introduced by the company this summer time. The foundations don’t embrace some sections initially included within the proposed regulation, like first-of-their-kind standards for software program utilized by public well being businesses and payers to be licensed by the ASTP/ONC.

Nevertheless, extra interoperability rules are in progress, in keeping with the federal authorities’s unified agenda. An ASTP/ONC spokesperson informed Healthcare Dive final week that the scope of the unique proposed rule and the variety of feedback made it difficult to finalize the proposed regulation in its entirety rapidly.

The HTI-3 ultimate rule focuses on data blocking exceptions, significantly these associated to reproductive healthcare. Suppliers, IT builders and data sharing exchanges are sometimes barred from blocking the move of digital well being knowledge, however regulators can create exceptions by means of rulemaking. 

The regulation permits actors to limit knowledge sharing if they’ve religion perception that folks in search of, acquiring, offering or facilitating reproductive healthcare might face authorized jeopardy if that data was shared.

The newest rule comes as some consultants and policymakers have raised issues that well being knowledge may very well be used to prosecute ladies and clinicians in states which have largely banned abortion or added new restrictions. 

Sufferers are more and more touring to states the place the process is authorized, in keeping with the Guttmacher Institute. About 92,100 individuals traveled out of state for an abortion within the first six months of 2023, in comparison with 40,600 within the first six months of 2020.

The Biden administration has already taken different steps in a bid to strengthen privateness protections for sufferers in search of reproductive healthcare. 

This spring, the HHS’ Workplace for Civil Rights finalized a rule that prohibits HIPAA-covered entities from disclosing protected well being data for investigations, or to impose authorized legal responsibility if the care was authorized within the state it was acquired.

Nevertheless, Texas Legal professional Normal Ken Paxton sued to dam the rule this fall, arguing it will unlawfully prohibit state regulation enforcement investigations.