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Compliance Checkup: New Rule Pertaining to Information blocking and its Effect on Health Care Providers
on June 15, 2021
Have you reviewed your facility’s access methods to patient information recently? If not, you may want to consider doing so because The Office of the National Coordinator for Health Information Technology (ONC) recently implemented a new rule affecting the accessibility of health care information in the United States.
The 21st Century Cures Act and the Final Rule implements interoperability requirements and went into effect on April 5, 2021. Health care providers, health IT developers of certified health IT, and health information networks/exchanges (Actors) must comply with the interoperability and information blocking provisions.
If this seems like technical jargon that is difficult to parse out, you are in good company. Interoperability with respect to health information technology is defined as information technology that enables the secure exchange and use of electronic health information with other health information technology and allows for complete access, exchange, and use of all electronically accessible information for authorized use under applicable State or Federal law. In other words, it is a law that requires providers to be more flexible in making electronic Protected Health Information (PHI) available to certain individuals, namely patients, in an electronic manner that is not unreasonable and in the form they request. Think of patient portals and full access to medical records in the same way you engage with your bank and similar electronic sites.
As such, the triggering event of this new rule is generally a request for electronic health information (EHI). According to the law, when a patient asks his or her physician for their medical records in electronic form, the physician must give the patient access unless an exception applies. Likewise, if a referring provider requests information from another provider involved in the patient’s care, the provider must give access to this information in the form or fashion requested absent an exception or they will be in violation of information blocking.
What Exactly is Information Blocking?
Information blocking is defined as any practice that is likely to interfere with, prevent, or materially discourage access to, exchange, or use of EHI. A health care provider cannot knowingly prevent, materially discourage, or otherwise inhibit access to EHI when authorized and requested.i
The purpose and effect of the ONC Final Rule is to promote and allow accessibility of EHI between health care networks, providers, and patients when authorized and requested. Providers must give patients access to this information in the manner requested unless they fall into one of the eight exceptions identified as reasonable and necessary activities that do not constitute information blocking.
The following are exceptions to fulfilling requests to access, exchange, or use EHI that are not considered information blocking, provided certain conditions are met:
- Preventing Harm Exception: An actor engages in practices that are reasonable and necessary to prevent harm to a patient or another person.
- Privacy Exception: An actor does not fulfill a request to access, enhance or use EHI in order to protect an individual’s privacy.
- Security Exception: An actor interferes with the access, exchange, or use of EHI in order to protect the security of EHI.
- Infeasibility Exception: An actor does not fulfill a request to access, exchange, or use EHI due to the infeasibility of the request.
- Health IT Performance Exception: An actor takes reasonable and necessary measures to make health IT temporarily unavailable or to degrade the health IT’s performance for the benefit of its overall performance.
Exceptions for procedures that are not considered information blocking provided certain conditions are met are:
- Content and Manner: An actor limits the content of its response to a request to access, exchange or use EHI or the manner in which it fulfills a request.
- Fees Exception: An actor charges fees, including fees that result in a reasonable profit margin, for accessing, exchanging, or using EHI.
- Licensing Exception: An actor licenses interoperability elements for EHI to be accessed, exchanged, or used.
If an actor is in violation of these provisions, it could face penalties of up to $1 million per violation. Therefore, we recommend that you conduct a thorough analysis of the various medical records requests that come through your office and evaluate your practice’s response. If your practice is unable to provide medical records access in an electronic form, including direct access to your patients’ medical records through a portal, etc., you may consider what, if any, exceptions your practice could claim. This is a substantially technical law so you may also consider engaging your IT vendor to ensure you understand your EMR capabilities, access, etc. If you have any questions about information blocking or interoperability, or if you need help identifying ways to fit into one of these exceptions, please contact a health care attorney at Brouse, and we would be happy to help.
This blog is intended to provide information generally and to identify general legal requirements. It is not intended as a form of, or as a substitute for legal advice. Such advice should always come from in-house or retained counsel. Moreover, if this Blog in any way seems to contradict advice of counsel, counsel's opinion should control over anything written herein. No attorney client relationship is created or implied by this Blog. © 2024 Brouse McDowell. All rights reserved.