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21st Century Cures Act Interoperability and Information Blocking Rules: Who is an Actor?




The deployment of the Office of National Coordinators (ONC)21stCentury Cures Act interoperability and information blocking rulesrecalls how HIPAA has been deployed over the past 25 years. Since May 1, 2021, players are required to comply with information blocking rules. However, it will be some time before all actors know who they are and for complaints of information blocking to be considered real cases of information blocking, by which time the sanctions that have yet to be applied. finalized may also need to be adjusted.

While the ONC defined actors ashealth care providers, health IT developers of certified health IT and health information exchanges or networksin the final rule and published guidance on theirwebsite, there is still some uncertainty as to who the information blocking rules apply to. Confusion can arise from the unfamiliarity of some healthcare providers and healthcare IT developers as never having been regulated or supervised by the ONC. There also appears to be an overlap between what the ONC’s information blocking rules protect against and what and how the Office for Civil Rights protects under the HIPAA privacy rule. In addition, providers and payers are generally regulated and supervised by CMS, however, CMS has not addressed any of the potential incentives that providers would be subject to in the event of a breach of information blocking and payers have never been required to do so. ” use certified electronic health records.

It is understandable that the information blocking prohibitions apply to a healthcare IT developer who develops or offers certified healthcare information technology under the ONC certification program. In the rules, the ONC clarified that the information blocking prohibitions apply to a healthcare IT developer as long as the developer has one or more healthcare IT modules certified under the ONC Health IT certification program at the time. where he engages in a practice which is the subject of an information blocking request. However, ONC has created an exception for healthcare providers who have developed their own healthcare IT for their own use.

When the ONC defined the health care provider based on the definition provided by the Public Health Services Act (42 USC 300jj) (PHSA definition), it included a significant number of providers who had never been regulated by the ONC. Many of the types of health care providers that were swept into the definition of actor and subject to the information blocking provisions were not included in the incentive programs that made funding available to the public. ‘purchasing certified electronic health records (e.g. outpatient surgical centers, long-term care facilities and therapists), there are no quality payment incentive programs they can participate in and some do. do not use certified EHRs. Healthcare providers should be aware that, in addition to guidance issued by the ONC specifying that information blocking applies to any healthcare provider who meets the definition of the PHSA, that any of the technologies health information whether or not the provider uses is certified in accordance with the ONC Health IT certification. Program, the catch-all clause at the end of the PHSA definition allows any other category of healthcare facility, entity, practitioner or clinician deemed appropriate by the Secretary of HHS to be swept into the definition actor.

In the final rule, the ONC combined two categories of actors, health information exchange and health information networks, and adopted a functional definition for both. A health information network or exchange refers to an entity that connects and exercises control over technologies and services that enable the exchange of information between and among more than two other unaffiliated entities for processing operations. , payment or health care. Considering all the healthcare IT developers, cloud service providers and data aggregators who offer services to support interoperability and communication to support healthcare e-commerce, including coordination of care and delivery, l ‘Patient engagement and the promotion of the social determinants of health to achieve equality of care, there is a myriad of entities that link multiple provider and / or payor organizations to coordinate patient care or benefits. These entities could unintentionally perform the functions described in the definition of health information exchange or network without even knowing that they are considered actors under the information blocking rules.

2021 Epstein Becker & Green, PC All rights reserved.Revue nationale de droit, volume XI, number 173

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