21st Century Cures Act and Open Notes – Your Cheat Sheet

June 14, 2021

The 21st Century Cures Act was signed into law December 2016. It was designed to help accelerate medical product development and bring new innovations to patients faster. It included modernizing clinical trial designs, expedited options for regenerative medicine therapies, and a “breakthrough devices” program. 21st Century. What’s not to like? It’s like Mom and apple pie.

Well, there’s a provision related to “information blocking” that took effect on April 5, 2021. It’s popularly referred to as the Open Notes Rule.

Information blocking is any practice that physicians or health information technology developers use to make it more challenging for others to access, exchange or use electronic health information (EHI) when those other parties have a right to the information.

In technical jargon, 45 CFR § 171.103 defines information blocking as a practice that:

  1. Is likely to interfere with access, exchange or use of electronic health information; and
  2. A health care provider knows that such practice is unreasonable and is likely to interfere with access, exchange, or use of electronic health information.

Simply put, and most importantly, patients have a right to access their clinical notes on demand.

Repeat, patients have a right to their clinical notes on demand.

Other “data elements” patients have a right to access:

  1. Vital signs
  2. Medication list
  3. Assessment and plan of treatment
  4. Care team members
  5. Clinical notes (except psychotherapy notes and information compiled in anticipation of a lawsuit or administrative hearing)
  6. Patient goals
  7. Health concerns
  8. Labs and medications

Yes, prevention of information blocking is not absolute. There are exceptions.

  1. Preventing harm to a patient or another person.
  2. Protecting an individual’s privacy.
  3. Protecting the security of electronic health information (EHI).
  4. Infeasibility.
  5. Health IT performance (e.g., to operate properly, health IT must be maintained and sometimes taken offline).

The medical practice would have the burden of demonstrating why these exceptions are relevant.

What if the practice has no electronic record keeping system and relies on paper charts? Practices may continue as before. Information blocking only refers to electronic records. If you have no electronic records, the 21st Century Cures Act likely has little effect on your practice. If you are not using electronic records, you would not be “information blocking.”

If you ARE using electronic records, call your EHR vendor and ask how THEY plan to comply with the 21st Century Cures Act. What information will be more or newly available to your patients? Ask if your EHR vendor will provide additional training, and, if so, how it will be delivered.

Some have asked if the fax machine will be retired. HHS chose specifically against disallowing it. So, fax machines are still in play.

Are there penalties for non-compliance?

Hard to say. Under the Cures Act, health care providers who engage in information blocking may be “referred to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary [of HHS] sets forth through notice and comment rulemaking.” Early on, non-compliance may be addressed mostly through education. That was how HIPAA non-compliance was addressed in the early years. But, over time, education as a remedy morphed into draconian penalties. Stay tuned.

For most practices, I do not believe there will be substantive changes, if any. One author on Medscape penned a thoughtful response.

Not sure what the big deal is.

Patients forever could request copies of their notes. Long before EHRs.

Just avoid putting things in notes that would insult a patient.

Use common sense.

If a person weighs 400 pounds, state that, but avoid ‘massively obese’, or worse.

If they have B.O. then couch it in a more kindly way such as poorly groomed.

Never put that their last doctor or primary care doctor missed the colon cancer because they did not accurately work up iron deficiency anemia.

Be careful describing psychiatric conditions. In other words, don’t put JPN as a diagnosis which I saw once from a PCP. (Just plain nuts).

If a patient is a jerk…. which many are, just describe them as a bit demanding rather than hostile or ….. a jerk.

And when it comes to sexual identity or anything related… just state the facts without an editorial opinion.

All common sense… and 99 percent of us are doing it correctly now I would guess.

What about the acronyms many of us use? Well, most are confined to paper records, so likely not relevant. “WNL” means “Within Normal Limits.” Some cynically interpret that acronym as “We Never Looked.” “SOB” means “Shortness of Breath.” Not son of a female canine. The list goes on and on. These acronyms generally are not part of dropdowns in electronic records.

So, there it is.  Since April 5, 2021, it is no longer be legal to only release notes upon request. Instead, healthcare professionals using certified EHRs must publish them in their patient portals so patients can access them whenever they want.

What do you think? Good? Bad? Same as before?

This article was written by founder of Medical Justice, Jeff Segal, JD, MD. The original article can be found here. If you have any questions or would like to know more, please schedule a consult at info@byrdadatto.com.

ByrdAdatto attorney Jeff Segal

Jeffrey J. Segal, MD

Jeffrey J. Segal was a neurosurgeon in private practice before beginning the second phase of his career as an attorney in the health care field.