Passed as part of the 21st Century Cures Act in 2016, the rule is intended to encourage innovation in medical research and expand patients’ control over their protected health information (PHI). To accomplish this goal, the definition of electronic health information (EHI) that providers must share with patients in a timely and affordable fashion will expand.
The expansion of the definition is expected to improve healthcare data interoperability in the hope that it will ease the flow of electronic health information, among developers, between providers and patients, providers and EHR vendors, etc.
Hospitals “– not fully prepared” for Cures Act Information Blocking Rule
In their letter to the HHS Secretary asking for the delay, the group of hospitals and medical associations asserted there was “…no clear definition of EHI, and there is a lack of a technical infrastructure to support its secure exchange.”
The group also cited continuing supply-chain delays and other issues as reasons for seeking a one-year delay in compliance with information blocking requirements. They also asked HHS to send corrective action warning communications to providers/clinicians prior to imposing any monetary disincentives or beginning a formal investigation.
Dan Lebovic, a Senior Regulatory Attorney at Compliancy Group, expressed doubt about HHS granting another delay.
“This has all the hallmarks of a legal “Hail Mary,” given the timing of the letter just 10 days before the rule is scheduled to go into effect,” said Lebovic.
“Providers have known this was coming since its passage in 2016. HHS delayed implementation in 2020 and 2021, and I’m not optimistic that it will happen again.“
If no final reprieve is granted, providers who fail to meet the rule’s requirements would likely violate the Cures Act information blocking provision and face penalties. Investigators from the HHS Office for Civil Rights have already prioritized right of access enforcement over the past three years, resulting in 41 civil monetary penalties and fines. Enforcement of the Cures Act rule against information blocking is yet another tool HHS has to ensure patients can view and access their medical records.