ONC Cures Act Final Rule Information Blocking Provisions

Question 1

ONC Cures Act Final Rule Information Blocking Provisions

Answer 1

The ONC Cures Act Final Rule codified a definition of information blocking, as well as eight exceptions to the information blocking prohibition, with a compliance date of November 2, 2020 (which the IFC changed to April 5, 2021).

Question 2

Any practice that, except as required by law or covered by an exception, is likely to interfere with access, exchange, or use of EHI may be considered

Answer 2

information blocking.

Question 3

What are two different intent standards?

Answer 3

1) one applicable to health IT developers of certified health IT, HIEs, and HINs, and
2) another applicable to health care providers:

Question 4

Standard 1

Answer 4

Health IT developers of certified health IT, HIEs, and HINs engage in information blocking when they know, or should know, that the practice is likely to interfere with access, exchange, or use of EHI.

Question 5

Standard 2

Answer 5

Health care providers engage in information blocking only when they know that the practice is unreasonable and is likely to interfere with access, exchange, or use of EHI.

Question 6

The ONC Cures Act Final Rule also defined EHI as

Answer 6

electronic protected health information (as defined under the Health Insurance Portability and Accountability Act of 1996, and its implementing regulations, as amended (“HIPAA”)) to the extent that it would be included in a designated record set (as defined under HIPAA), regardless of whether the group of records are used or maintained by or for a HIPAA covered entity.

Question 7

EHI specifically excludes

Answer 7

1) psychotherapy notes (as defined under HIPAA) as well as
2) information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding.

Question 8

The ONC Cures Act Final Rule further limited the definition of EHI to .

Answer 8

data elements containedin the United States Core Data for Interoperability (“USCDI”) standard until May 2, 2022.5 The IFC delays this transition date for the definition of EHI to October 6, 2022

Question 9

In addition to defining information blocking and EHI, the ONC Cures Act Final Rule established two categories of information blocking exceptions, as follows:

Answer 9

1) Exceptions that involve not fulfilling requests to access, exchange, or use EHI
2) Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI

Question 10

Exceptions that involve not fulfilling requests to access, exchange, or use EHI are:

Answer 10

Preventing Harm Exception;
Privacy Exception;
Security Exception;
Infeasibility Exception; and
Health IT Performance Exception.

Question 11

1) The amendment of the Civil Monetary Penalties Law (CMPL), 42 U.S.C. 1320a–7a, by the 21st Century Cures Act (Cures Act), Public Law 114– 255, sec. 5003, authorizing HHS to impose CMPs, assessments, and exclusions upon individuals and entities that engage in fraud and other misconduct related to HHS grants, contracts, and other agreements (42 U.S.C. 1320a–7a(o)–(s)); (2) the amendment of the Public Health Service Act (PHSA), 42 U.S.C. 300jj–52, by the Cures Act authorizing OIG to investigate claims of information blocking and providing the Secretary of HHS (Secretary) authority to impose CMPs for information blocking; and (3) the increase in penalty amounts in the CMPL effected by the Bipartisan Budget Act of 2018 (BBA 2018),

Answer 11

.