It’s the prototypical nightmare. You’re back in high school, and it’s your turn to get up before the class and deliver a speech on Jurassic-era dinosaurs or the causes of WWI or whatever topic had been assigned to you weeks before. It is only then that you realize to your absolute horror that you failed to prepare any remarks on the subject. Then, you wake up; it was only a dream. For some, nightmares involving due dates and non-preparedness have become part of their waking reality.

On September 26, the American Hospital Association (AHA), along with nine other national entities—including America’s Essential Hospitals and the American Medical Association (AMA)—sent a letter to Secretary Xavier Becerra of the U.S. Department of Health and Human Services (HHS), asking for the postponement of a looming deadline.

A Bit of Background

On October 6, healthcare providers, health IT developers and others must start sharing all electronic health information in a designated record set, effectively prohibiting entities from engaging in what is officially termed “information blocking” (IB). First described in the 21st Century Cure’s Act (2016), IB as defined in later regulations (45 CFR 171.103) is activity that is “likely to interfere with access, exchange, or use of electronic health information.”

Such information (EHI) was originally limited to the data elements listed in the United States Core Data for Interoperability (USCDI) standard. As of October 6, however, the scope of EHI will be expanded to include all electronic information in a healthcare provider’s designated record set. This represents a significant expansion of what information providers must make available to patients without unnecessary delay.

Behind the Beef

The signatories to the above-referenced letter are indicating that the responsible parties are unprepared to meet the October deadline and, in fact, are struggling to interpret some of the key provisions of the regulation. The letter states, in part:

A chief factor limiting compliance readiness is the widespread inability to support access, exchange, and use of EHI. There is no clear definition of EHI and there is a lack of a technical infrastructure to support its secure exchange. There are widely divergent approaches to how each healthcare stakeholder is interpreting what data is ePHI, DRS, and EHI. Many stakeholders are still confused by the Office of the National Coordinator’s (ONC) EHI infographic.  Since providers and other Actors will be held accountable for EHI interoperability, consistency in EHI interpretation is critical. Moreover, significant confusion continues to exist on how the eight information blocking exceptions are applied when EHI cannot or should not be exchanged.

The medical organizations that are a party to the letter are also concerned with the potential harm that could occur with the required release of sensitive health records, such as substance use disorder, adolescent, mental health and reproductive information. They conclude that, if their own large national organizations are unable to fully discern the law’s requirements, how can smaller entities, such as individual hospitals, be expected to properly interpret and successfully execute these regulations?

A final point driven home in the AMA, et al. communication to HHS involves requirements for vendors, i.e., those who are expected to assist providers in complying with these rules. The vendor deadline for compliance is December 31—three months after the provider deadline. Yet, according to the letter to HHS, vendor readiness is also lagging.

A Reasonable Request

The collective medical organizations are requesting that HHS postpone the compliance date by one year to allow vendors and providers time to better understand the nuances of the regulations and to prepare for their implementation. The group also requests that the government issue corrective action or warnings for those found to be noncompliant before imposing monetary penalties or starting formal investigations. This request is key. The 21st Century Cures Act created a process for the public to report claims of possible information blocking, and actors could be fined up to $1 million per information blocking incident.