Background

Senator Lamar Alexander (R-TN) was a primary proponent of the new provisions, citing the difficulty that many Americans have had in gaining access to their full medical records.  Many are aware of the hours or days it often takes to obtain their own health information, and so there has been a push by many in Congress to infuse immediacy and transparency into the process.  One witness before a congressional hearing indicated it often took months to obtain certain types of medical records, such as “audit trails,” that are typically required in connection with legal proceedings.

The Proposed Rule specifically takes aim at so called “data blocking,” a technique used by tech companies and other health-related entities to limit the sharing or transfer of certain types of information from medical files.  The Rule specifically requires manufacturers to build software that can easily export a patient’s entire medical record.  In addition, the Rule requires health systems to provide these medical records electronically to the patient—and at no cost.  The health information transmission process will include the use of certain apps available on the patient’s smart phone!

Pushback

Because of the massive refit required by the government’s proposals in this arena, and the limited amount of time they have been given to accomplish these objectives, the CEO of one of the nation’s largest providers of electronic medical record (EMR) technology, Epic, has written a letter to HHS that lists several concerns with the proposed requirements.  Before sending it on to the secretary of HHS, Epic’s CEO, Judith Faulkner, invited hospitals and health systems across the country to add their signatures to the letter.  She was able to get 60 signatories, though some of the largest hospital systems, and some of the largest American tech companies (e.g., Google, Apple, Microsoft), declined to add their imprimatur to the letter.

The letter sent to HHS was obtained by CNBC, who then released details of its contents.  The letter reads, in part:

“While we support HHS’ goal of empowering patients with their health data and reducing costs through the 21st Century Cures Act, we are concerned that ONC’s Proposed Rule on interoperability will be overly burdensome on our health system and will endanger patient privacy. Specifically, the scope of regulated data, the timeline for compliance, and the significant costs and penalties will make it extraordinarily difficult for us to comply.”

Counterproposal

According to CNBC, the letter from Epic’s Faulkner goes on to provide suggested changes to the HHS proposals, to include the following:

• More clarity concerning health information related to family members is requested.
• Additional time to comply with certain proposed mandates is requested.  According to Epic, at least 12 months will be needed to prepare for the required changes, and 36 months will be needed for “development of new technology required by the rule.”

According to media and government sources, the letter was received and reviewed by officials at HHS.  A spokesperson for the agency provided the following comment: “We appreciate all stakeholder feedback as we continue to finalize the rules. Our ultimate goal is to ensure that patients are able to easily access their electronic medical records.”

It remains to be seen what will become of this clash between government and corporate titans.  Obviously, HHS’ ONC division will need to take seriously the concerns expressed by Epic and its 60 supporting entities.  The financial and time burdens as outlined in the Epic letter cannot be ignored.  From a practicality perspective, the government may end up having to give ground on these points.  Hopefully, the parties will be able to agree on a sensible and workable solution to achieving their joint goal of enhancing patients’ access to their medical records.

As always, should you have any questions, please reach out to us at info@miramedgs.com.