As your technology partner, Assertus, its affiliates, and subsidiaries are committed to fulfilling our client’s needs and build relationships on an added value principle. Our business philosophy is to strive and design high-quality services and products aligned with the healthcare industry compliance standards.
Therefore, we are tacking the 21st Century Cures Act[1] and sharing this summary of the Final Rule mandate. You will find this summary a high-level overview of some of the central elements of Information Blocking. If you have any related questions regarding the 21st Century Cures Act’s impacts on the Assertus services and/or products, don’t hesitate to contact us. Our team is ready to assist you.
WHAT IS INFORMATION BLOCKING? [2]
In General, the 21st Century Cures Act defines Information Blocking as:
- a business, technical, and organizational practice of an «Actor»; that know, or should have known,
- Their practice prevents or is likely to interfere with the access, exchange, or use of electronic health information(E.H.I.).
- Except if those practices are required by law or covered by an exception.
WHO IS AN ACTOR?[3]
The 21st Century Cures Act stated as «Actors» four types of entities who must comply with info blocking requirements:
- Health care providers (as defined under 42 U.S.C. 300jj);
- Health I.T. developers of certified health I.T.; and
- Health Information Networks (HINs) or Health Information Exchange (H.E.I.)s (HINs and H.E.I.s had being combined into one defined type in the Final Rule).
INFORMATION BLOCKING EXAMPLES:[4]
Information Blocking can occur in many forms. These include:
- Practices that restrict authorized access, exchange, or use of E.H.I.;
- Implement health I.T. in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging, or using E.H.I.;
- Implement health I.T. in ways that are likely to restrict the access, exchange, or use of E.H.I. to export complete information sets or transition between health I.T. systems. This would include acts that make transitions between certified health information technologies more challenging;
- Actions that lead to fraud, waste, or abuse, or impede innovations and advancements in health information access, exchange, and use, including care delivery enabled by health I.T.
INFORMATION BLOCKING EXCEPTIONS[5]:
When an Actors practice meets the conditions and/or requirements of one or more Exceptions as established, such practice will not be considered Information Blocking.
The Exceptions are divided into two categories:
- Exceptions that involve not fulfilling requests to access, exchange, or use E.H.I.:
- Preventing Harm
- Privacy
- Security
- Infeasibility (tighter deadline for compliance)
- Health I.T. performance
- Exceptions that involve procedures for fulfilling requests to access, exchange, or use E.H.I.:
- Content and manner
- Fees
- Licensing
EVALUATION OF EXCEPTIONS:
If an Actor practice does NOT meet all the conditions and/or requirements of an Exception, it will NOT automatically constitute Information Blocking.
- All practices will be evaluated on a case-by-case basis.
- The establishment of the exception shall be reasonable and necessary.
- All Exceptions shall address for or mitigate a significant risk.
- Analysis and establishment must be subject to strict conditions.
ENFORCEMENT DATE
April 5, 2021, marked the Compliance Date for all Actors to comply with the Information Blocking Provision under the 21st Century Cures Act Final Rule. Further information can be found at https://www.healthit.gov/curesrule/.
[1] https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification
[2] https://www.healthit.gov/topic/information-blocking
[3] ONC21stCenturyCuresActFinalRuleOverview.pdf (healthit.gov)
[4] https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification
[5] https://www.healthit.gov/cures/sites/default/files/cures/2020-03/InformationBlockingExceptions.pdf