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

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Medical Justice provides consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. We also provide counsel specific to COVID-19. If you are navigating a medico-legal obstacle, visit our booking page to schedule a consultation – or use the tool shared below.

“Can Medical Justice solve my problem?” Click here to review recent consultations…

all. Here’s a sample of typical recent consultation discussions…

  • Former employee stole patient list. Now a competitor…
  • Patient suing doctor in small claims court…
  • Just received board complaint…
  • Allegations of sexual harassment by employee…
  • Patient filed police complaint doctor inappropriately touched her…
  • DEA showed up to my office…
  • Patient “extorting” me. “Pay me or I’ll slam you online.”
  • My carrier wants me to settle. My case is fully defensible…
  • My patient is demanding an unwarranted refund…
  • How do I safely terminate doctor-patient relationship?
  • How to avoid reporting to Data Bank…
  • I want my day in court. But don’t want to risk my nest egg…
  • Hospital wants to fire me…
  • Sham peer review inappropriately limiting privileges…
  • Can I safely use stem cells in my practice?
  • Patient’s results are not what was expected…
  • Just received request for medical records from an attorney…
  • Just received notice of intent to sue…
  • Just received summons for meritless case…
  • Safely responding to negative online reviews…

We challenge you to supply us with a medico-legal obstacle we haven’t seen before. Know you are in good hands. Schedule your consultation below – or click here to visit our booking page.

 


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 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: 

  • 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.  
  • Labs and medications. 

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

  • Preventing harm to a patient or another person.  
  • Protecting an individual’s privacy.  
  • Protecting the security of electronic health information (EHI).  
  • Infeasibility.  
  • 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 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? Let us know your thoughts in the comments below.

Medical Justice provides consultations to doctors facing medico-legal obstacles. We have solutions for doctor-patient conflicts, unwarranted demands for refunds, online defamation (patient review mischief), meritless litigation, and a gazillion other issues. We also provide counsel specific to COVID-19. If you are navigating a medico-legal obstacle, visit our booking page to schedule a consultation – or use the tool shared below.

“Can Medical Justice solve my problem?” Click here to review recent consultations…

all. Here’s a sample of typical recent consultation discussions…

  • Former employee stole patient list. Now a competitor…
  • Patient suing doctor in small claims court…
  • Just received board complaint…
  • Allegations of sexual harassment by employee…
  • Patient filed police complaint doctor inappropriately touched her…
  • DEA showed up to my office…
  • Patient “extorting” me. “Pay me or I’ll slam you online.”
  • My carrier wants me to settle. My case is fully defensible…
  • My patient is demanding an unwarranted refund…
  • How do I safely terminate doctor-patient relationship?
  • How to avoid reporting to Data Bank…
  • I want my day in court. But don’t want to risk my nest egg…
  • Hospital wants to fire me…
  • Sham peer review inappropriately limiting privileges…
  • Can I safely use stem cells in my practice?
  • Patient’s results are not what was expected…
  • Just received request for medical records from an attorney…
  • Just received notice of intent to sue…
  • Just received summons for meritless case…
  • Safely responding to negative online reviews…

We challenge you to supply us with a medico-legal obstacle we haven’t seen before. Know you are in good hands. Schedule your consultation below – or click here to visit our booking page.

 


Jeffrey Segal, MD, JD

Chief Executive Officer and Founder

Dr. Jeffrey Segal, Chief Executive Officer and Founder of Medical Justice, is a board-certified neurosurgeon. Dr. Segal is a Fellow of the American College of Surgeons; the American College of Legal Medicine; and the American Association of Neurological Surgeons. He is also a member of the North American Spine Society. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country’s leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

Dr. Segal was a practicing neurosurgeon for approximately ten 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 a M.D. from Baylor College of Medicine, where he also completed a neurosurgical residency. Dr. Segal served as a Spinal Surgery Fellow at The University of South Florida Medical School. He is a member of Phi Beta Kappa as well as the AOA Medical Honor Society. Dr. Segal received his B.A. from the University of Texas and graduated with a J.D. from Concord Law School with highest honors.

In 2000, he co-founded and served as CEO of DarPharma, Inc, a biotechnology company in Chapel Hill, NC, focused on the discovery and development of first-of-class pharmaceuticals for neuropsychiatric disorders.

Dr. Segal is also a partner at Byrd Adatto, a national business and health care law firm. Byrd Adatto was selected as a Best Law Firm in the 2021 edition of the “Best Law Firms” list by U.S. News – Best Lawyers. With decades of combined experience in serving doctors, dentists, and other providers, Byrd Adatto has a national pedigree to address most legal issues that arise in the business and practice of medicine.

Jeffrey Segal, MD, JD
Chief Executive Officer & Founder

Jeffrey Segal, MD, JD is a board-certified neurosurgeon and lawyer. In the process of conceiving, funding, developing, and growing Medical Justice, Dr. Segal has established himself as one of the country's leading authorities on medical malpractice issues, counterclaims, and internet-based assaults on reputation.

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