On October 6, 2022, information blocking regulations went into effect, despite providers’ pleas to the Department of Health and Human Services (HHS) to delay the deadline by a year.
Request for Delay
Some of the groups asking for the delay included the American Academy of Family Physicians, American Health Care Association, American Hospital Association, and the American Medical Association. The providers noted that “based upon feedback from our members that continues to build, it is evident that both healthcare providers, clinicians and vendors are not fully prepared for the October 6th deadline.” Therefore, they requested that HHS “consider both postponing for a period of one-year the information blocking compliance deadlines – including October 6th, as well using corrective action warning communications to providers/clinicians prior to imposing any monetary disincentives or beginning a formal investigation.”
The providers cite the “chief factor limiting compliance readiness” as the “widespread inability to support access, exchange, and use of EHI.” They requested that federal agencies under the HHS umbrella provide more education “targeted to the provider/clinician community with a particular focus on small, medium and lesser-resourced organizations,” including best practices and implementation guides that providers can reference as they get ready for the investigation and disincentive phase of information blocking regulations.
The organizations also referred to “significant confusion” surrounding the eight information blocking exceptions and how to protect sensitive health records, such as those related to substance use disorder or reproductive information.
ONC Response
Instead of postponing the regulations, the Office of the National Coordinator for Health Information Technology (ONC) released a statement/blog post with 8 reminders for the information blocking regulations and a link to a new webpage with links to many information blocking resources, including regulatory information, fact sheets, FAQs, and blog posts.
The first reminder is that the information blocking definition’s limitation on the scope of electronic health information (EHI) is lifted as of October 6, 2022. Second, information blocking actors’ practices do include acts and omissions that could prevent, materially discourage, or otherwise inhibit the access, exchange, and use of EHI.
Third, there are eight exceptions to the information blocking provision, but they are not “one size fits all.” The eight exceptions are: preventing harm, privacy, security, infeasibility, health IT performance, licensing, fees, and content and manner. ONC noted that everyone, but especially information blocking actors, should “become familiar with each of the exceptions and the contexts in which they can be met.”
The fourth reminder is that not all electronic health information is EHI under the regulatory definition and if such information is not EHI, it is not covered by the information blocking regulations. The same electronic protected health information that an individual has a right to access (and request an amendment to) under the HIPAA Privacy Rule is the same electronic protected health information that information blocking actors cannot “block.” Under this reminder, ONC reiterates that information blocking regulations apply not only to practices where the individual is seeking access to their own EHI, but also practices associated with business-to-business relationships, such as those to support treatment, payment, and health care operations. ONC again notes that “the ePHI in your DRS [Designated Record Set] constitutes your EHI” for information blocking regulation purposes.
Fifth, the way electronic health information is made available for access, exchange, and use can vary based on who the information blocking actor is and who it is that is seeking to access, exchange, or use an information blocking actor’s electronic health information.
Sixth, ONC notes that information blocking is about the electronic health information, irrespective of which type of technology is used by information blocking actors. It also does not matter if ONC-certified health IT is involved or not.
ONC also notes that the use of information blocking exceptions are to provide “clear notification to requestors whether their request to access, exchange, or use EHI is delayed or denied.”
Finally, the Cures Act prohibits ONC from disclosing information blocking claims or information that could be used to identify the source of the information, other than as required to carry out the purpose of the information blocking statute. These claims and information are exempt from mandatory disclosure under the Freedom of Information Act (FOIA).
Conclusion
As we are just weeks out from the implementation of the deadline, time will tell how “ready” providers really were for the rule to take effect.