Determine what impact
The 21st Century Cures Act legislation was enacted with the goal of increasing choice and access for patients and providers in 2016. The law authorizes funding to address the opioid epidemic and improve mental health services. Current funding encourages expedited approval of new drugs, devices, and treatments.
As of October 6, 2022, the definition of electronic health information (EHI) in the 21st Century Cures Act expands beyond the United States Core Data for Interoperability (USCDI) Version 1 to include all electronic Protected Health Information (ePHI) that a patient has access to under the Health Insurance Portability and Accountability Act (HIPAA) and excludes only psychotherapy notes and certain records compiled for use in criminal action.
Information Blocking exceptions
Currently, the term “electronic health information” or “EHI” is limited to elements listed in the United States Core Data for Interoperability Standard (USCDI) and is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.
In response to the COVID-19 pandemic, certain portions of the 21st Century Cures Act have been implemented into new privacy regulations found at 45 C.F.R. Part 171.
Practices that interfere with access to EHI are considered information blocking with respect to categories of data currently identified in the USCDI. After October 6, 2022, this definition expands to including patient’s total medical record including billing and the complete medical record. Should the practice not comply information blocking is determined on a case-by-case basis.
Actionable violations include withholding test results. Withholding the sharing of test results until results are discussed with the patient is not required under state law can constitute information blocking.
Information blocking if a provider does not fulfill a request for EHI because of the infeasibility of the request due to either an uncontrollable event such as a public health emergency and the requested EHI cannot be segmented.
These eight practices will not constitute information blocking if all of the conditions of the applicable exception are met:
1. Preventing harm: practices that are reasonable and necessary to prevent harm to a patient or another person (45 C.F.R. § 171.201);
2. Privacy: not fulfilling a request to access, exchange, or use EHI in order to protect an individual’s privacy (45 C.F.R. § 171.202);
3. Security: interfering with the access, exchange, or use of EHI in order to protect the security of EHI (45 C.F.R. § 171.203);
4. Infeasibility: not fulfilling a request to access, exchange, or use EHI due to the infeasibility of the request (45 C.F.R. § 171.204);
5. Health IT performance: taking reasonable and necessary measures to make health IT temporarily unavailable or to degrade the health IT’s performance for the benefit of the overall performance of the health IT (45 C.F.R. § 171.205);
6. Content and manner: limiting the content of response to a request to access, exchange, or use EHI or the manner in which it fulfills a request to access, exchange, or use EHI (45 C.F.R. § 171.301);
7. Fees: Charging fees, including fees that result in a reasonable profit margin, for accessing, exchanging, or using EHI (45 C.F.R. § 171.302);
8. Licensing: licensing interoperability elements for EHI to be accessed, exchanged, or used (45 C.F.R. § 171.303).
Additional information about each exception, including each exception’s requirements, is available here.
Recommendations
As a rule, all EHR requests that are permitted by state and federal law should be fulfilled in a timely manner taking into consideration the technological and personnel capabilities of the provider.
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