By Jeff Segal, MD, JD, ByrdAdatto and Medical Justice

The 21st Century Cures Act was signed into law in December 2016. It was designed to help accelerate medical product development and bring new innovations to patients faster. It includes modernizing clinical trial designs, expedited options for regenerative medicine therapies and a "breakthrough devices" program.

Also included is 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.

Technically, 45 CFR § 171.103 defines information blocking as a practice that:

• Is likely to interfere with access, exchange or use of electronic health information; and
• A health care provider knows is unreasonable and is likely to interfere with access, exchange or use of electronic health information.

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

Other "data elements" patients have a right to access include:

• Vital signs;
• Medication list;
• Assessment and plan of treatment;
• Care team members;
• Clinical notes (except psychotherapy notes and information compiled in anticipation of a lawsuit or administrative hearing);
• Patient goals;
• Health concerns; and
• Labs and medications.

However, prevention of information blocking is not absolute. There are exceptions, including:

• Preventing harm to a patient or another person;
• Protecting an individual's privacy;
• Protecting the security of EHI;
• Infeasibility; and
• Health IT performance (i.e., 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 electronic health record (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. The U.S. Department of Health and Human Services (HHS) chose specifically against disallowing it. So, fax machines are still in play.

Are there penalties for non-compliance? It's 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, so 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 it is 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.

The bottom line is that since April 5, 2021, it is no longer legal to only release notes upon request. Instead, health care professionals using certified EHRs must publish them in their patient portals so patients can access them whenever they want.

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Jeffrey Segal, MD, JD, is chief executive officer and founder of Medical Justice, as well as a partner at ByrdAdatto, a national business and health care law firm. He was a practicing neurosurgeon for approximately 10 years, during which time he also played an active role as a participant on various state-sanctioned medical review panels designed to decrease the incidence of meritless medical malpractice cases. Dr. Segal holds an MD from Baylor College of Medicine, where he also completed a neurosurgical residency. He served as a spinal surgery fellow at the University of South Florida Medical School. Dr. Segal received his BA from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.