The 21st Century Cures Act (“Cures Act”) is a set of healthcare-related regulations signed into law effective December 13, 2016, with provisions spanning multiple healthcare sectors. The Cures Act created six ongoing Conditions and Maintenance of Certification:
Application Programming Interfaces (APIs): Health IT (such as Elation) must transparently make API available and continue to meet ongoing updated API requirements.
Assurances: Health IT must report that it does not block the exchange of electronic health information (EHI).
Attestations: Health IT must attest to complying with Conditions and Maintenance of Certification every six months, starting in April 2021.
Communications: Health IT cannot block communications about the usability, interoperability, security, user’s experiences, business practices, or manner of use of health IT.
Information Blocking: Health IT must not take any action that blocks patient information. Information Blocking is defined as "a practice that is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information" (§ 171.103).
Real-World Testing: Health IT must develop and implement a plan to fully test the real-world use of the EHR yearly. The first plan must be completed by the end of 2021 and implemented in 2022.
All healthcare actors, including providers, health IT developers, and health information networks/health information exchanges (HINs/HIEs) must comply with the Cures Act, including information blocking provisions. "Healthcare providers" includes all physicians and practitioners regardless of the practice model.
Health IT developers (such as Elation Health, Inc.)
an individual or entity, other than a health care provider that self-develops health IT for its own use, that develops or offers health information technology (as that term is defined in 42 U.S.C. 300jj(5)) and which has, at the time it engages in a practice that is the subject of an information blocking claim, one or more Health IT Modules certified under a program for the voluntary certification of health information technology that is kept or recognized by the National Coordinator pursuant to 42 U.S.C. 300jj-11(c)(5) (ONC Health IT Certification Program).
Actor: a health care provider, health IT developer of certified health IT, health information network or health information exchange.
Access: the ability or means necessary to make electronic health information (EHI) available for exchange or use.
Covered entity:
A health plan.
A health care clearinghouse.
A health care provider who transmits any health information in electronic form in connection with a transaction covered by this subchapter.
Designated record set:
A group of records maintained by or for a covered entity that is:
The medical records and billing records about individuals maintained by or for a covered health care provider;
(The enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for a health plan; or
(Used, in whole or in part, by or for the covered entity to make decisions about individuals.
For purposes of this paragraph, the term record means any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for a covered entity.
Electronic Health Information (EHI): individually identifiable information that is transmitted in any electronic media or maintained in electronic media to the extent that it would be included in a designated record set regardless of whether the group of records are used or maintained by or for the covered entity
After to October 6, 2022, EHI is defined as all electronic protected health information (ePHI)
Health IT: the area of IT involving the design, development, creation, use and maintenance of information systems for the healthcare industry
Health IT developer of certified health IT: an individual or entity, other than a health care provider that self-develops health IT for its own use, that develops or offers health information technology (as that term is defined in 42 U.S.C. 300jj(5)) and which has, at the time it engages in a practice that is the subject of an information blocking claim, one or more Health IT Modules certified under a program for the voluntary certification of health information technology that is kept or recognized by the National Coordinator pursuant to 42 U.S.C. 300jj-11(c)(5) (ONC Health IT Certification Program).
Interfere with or interference: to prevent, materially discourage, or otherwise inhibit.
