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21st Century Cures Act and EHR–Compliance in 2022

By Aaron Morein

The 21st Century Cures Act, referred to as the Cures Act, includes new guidelines regarding health information exchange. Non-compliance exposes practices to fines of up to $1 million per violation. The law, passed in 2016, enacted in 2020, had a deadline for compliance extended due to COVID-19.

Let’s take a look at the Cures Act, how it’s relevant to your practice, and how to stay in compliance.

21st Century Cures Act Summary

“The most important bill of the year,” as the Senate health committee chairman referred to it, allocates over $6 billion to health agencies like the NIH, modifies aspects of drug research and development, and makes critical updates to health information policy. At a glance, the Cures Act:

  • Funds initiatives aimed to combat the opioid crisis–increasing access to treatment and overdose reversal drugs, improving prescription drug monitoring, and dependency research.
  • Funds brain disease and cancer research.
  • Facilitates the development and approval process for genetically and variant protein targeted drugs for the treatment of rare diseases.
  • Waives the requirement for researchers to provide human-subjects’ informed consent in clinical testing when the drug or device “poses no more than minimal risk” and “includes appropriate safeguards to protect the rights, safety, and welfare of the human subject.”
  • Expedites the FDA Drug Approval Process. Previously, bringing new pharmaceuticals and devices to market or adding new indications for existing ones required clinical trial data. Companies often bemoan this process. For example, moving from phase I trials to the end of phase III takes around seven years. Costs typically approach $3 billion. Under certain conditions, they may now provide other, less rigorous evidence of safety and efficacy. This includes observational studies, insurance claims data, and even anecdotal data.

Let’s take a look at those provisions relevant to electronic health records (EHR), as well as how to remain in compliance with them.

21st Century Cures Act and EHR

A central focus of the Cures Act was enhancing interoperability, which it defines as:

“health information technology that enables the secure exchange of electronic health information with and…from other health information technology without special effort on the part of the user…[and] allows complete access of all electronically accessible health information for authorized use”.

In order to further ensure interoperability, the act takes special measures to prohibit information blocking, which it defines as:

“a practice by a healthcare provider, health IT developer, health information exchange, or health information network that…is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information”.

Interoperability enhances clinical decision making and reduces duplicate tests, treatments, and medical errors. The Federal Government has focused significant resources to promote the development and adoption of interoperable technology (ie EHR) since the turn of the millennium. It is an ongoing process, but it has made significant headway. Information blocking practices diminished the rewards of nation-wide interoperability standards. It is an end-game bug to be dealt with.

Those practices who are found to exhibit information blocking can be exposed to fines up to $1 million per violation.

The text goes on to detail categories of reasonable and necessary activities that do not constitute information blocking. For example, preventing a patient or another person from harm, protecting an individual’s privacy, and protecting EHR’s security are potentially valid reasons to deny a request of access, exchange, or use. The Final Rule outlines a total of eight exceptions–access them here.

Zoobook Systems EHR helps practices stay in compliance

The Office of the National Coordinator for Health Information Technology (ONC) has prioritized interoperability for nearly two decades now. A priority it remains, as new guidelines and updates will continue to roll out. Practices can struggle to keep up, finding the frequent updates to be confusing.

Compounding the problem, some medical and health record systems themselves have a difficult time adapting to new guidelines. For instance, a large proportion of practices use records formats that are designed not for exchange, but to record only what goes on in their office alone. A common example is the electronic medical record (EMR), which details a patient’s history in one practice or with one clinician.

Moreover, server-based and on-premise EHRs require local IT support to adapt to new guidelines at the expense of productivity.

Zoobook Systems designed EHR exclusively for mental health and addiction treatment services. It’s equipped for seamless health information exchange that ensures convenience and compliance. It’s cloud-based, too, meaning automatic software updates keep your practice agile to ever-changing regulations.

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