New laws under the Federal Cures Act will take effect on April 5, 2021. These laws stipulate that clinical notes must be among the electronic information available to patients “without delay” and free of charge. The new rules are designed to give patients and healthcare providers secure access to healthcare information. It appeals to the healthcare industry to adopt standardized application programming interfaces (APIs), which will allow individuals secure and easy access to structured electronic health information. Smartphone access must be implemented by October 6, 2022, under the new rule.
Under these new laws, eight types of notes are required to be shared. These include:
- Consultation notes
- Discharge summary notes
- History & physical
- Imaging narratives
- Laboratory report narratives
- Pathology report narratives
- Procedure notes
- Progress notes
There are two notes that the rules do not apply under the new laws. These include behavioral health (psychotherapy) and information compiled in reasonable anticipation of, or use in a civil, criminal or administrative action or proceeding.
There are eight information-blocking exceptions. Section 4004 of the 21st Century Cures Act defines practices that constitute information blocking and authorizes the Secretary of Health and Human Services (HHS) to identify reasonable and necessary activities that do not constitute information blocking.
A group called actors is referenced throughout the rule. Actors include healthcare providers, health information networks or health information exchanges, and health IT developers of certified health IT (such as electronic health record vendors).
The eight information-blocking exceptions are split into two categories:
- Exceptions that involve not fulfilling requests to access, exchange, or use EHI;
- Preventing Harm Exception: It will not be information blocking for an actor to engage in reasonable and necessary practices to prevent harm to a patient or another person, provided certain conditions are met.
- Privacy Exception: It will not be information blocking if an actor does not fulfill a request to access, exchange, or use EHI to protect an individual’s privacy, provided certain conditions are met.
- Security Exception: It will not be information blocking for an actor to interfere with the access, exchange, or use of EHI to protect the security of EHI, provided certain conditions are met.
- Infeasibility Exception: It will not be information blocking if an actor does not fulfill a request to access, exchange, or use EHI due to the infeasibility of the request, provided certain conditions are met.
- Health IT Performance Exception: It will not be information blocking for an actor to take reasonable and necessary measures to make health IT temporarily unavailable or to degrade the health IT’s performance for the benefit of the overall performance of the health IT, provided certain conditions are met.
- Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI.
- Content and Manner Exception: It will not be information blocking for an actor to limit the content of its response to a request to access, exchange, or use EHI or how it fulfills a request to access, exchange, or use EHI, provided certain conditions are met.
- Fees Exception: It will not be information blocking for an actor to charge fees, including fees that result in a reasonable profit margin, for accessing, exchanging, or using EHI, provided certain conditions are met.
- Licensing Exception: It will not be information blocking for an actor to license interoperability elements for EHI to be accessed, exchanged, or used, provided certain conditions are met.
Understanding and implementing this rule at your healthcare organization will be a team effort. Your risk management, legal, and compliance departments should all work together. For more information on the upcoming changes to the Federal Cures Act, we have provided several resources below:
Written law from the United States Congress
IT blocking exceptions from The Office of The National Coordinator for Health Information Technology