In a 2015 report to Congress, the Office of the National Coordinator for Health Information Technology (ONC) provided a definition of information blocking, an analysis of the extent to which the practice exists in the industry, and recommendations to address the issue.
What is Information Blocking?
Section 4004 of the 21st Century Cures Act (Cures Act) defines information blocking. In general, information blocking is a practice by a health care provider, health IT developer, health information exchange, or health information network that, except as required by law or specified by the Secretary of Health and Human Services (HHS) as a reasonable and necessary activity, is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information (EHI).
What are examples of practices that could constitute information blocking?
Section 4004 of the Cures Act specifies certain practices that may constitute information blocking:
- Practices that restrict authorized access, exchange, or use under applicable State or Federal law of such information for treatment and other permitted purposes under such applicable law, including transitions between certified health information technologies;
- Implementing health information technology in nonstandard ways that are likely to substantially increase the complexity or burden of accessing, exchanging, or using EHI;
- Implementing health information technology in ways that are likely to—
- Restrict the access, exchange, or use of EHI with respect to exporting complete information sets or in transitioning between health information technology systems; or
- Lead to fraud, waste, or abuse, or impede innovations and advancements in health information access, exchange, and use, including care delivery enabled by health information technology.
ONC also specifies in its recent notice of proposed rulemaking (proposed rule) numerous examples of practices that may implicate the information blocking provisions, which include, but are not limited to:
- Imposing formal or informal restrictions on access, exchange, or use of EHI.
- Implementing capabilities in ways that limit the timeliness of access, exchange, or use of EHI.
- Imposing terms or conditions on the use of interoperability elements that discourage their use.
- Discouraging efforts to develop or use interoperable technologies or services by exercising influence over customers, users, or other persons.
- Discriminatory practices that frustrate or discourage efforts to enable interoperability.
- Rent-seeking and opportunistic pricing practices.
What are potential reasonable and necessary activities that would not constitute information blocking?
Section 4004 of the Cures Act authorizes the Secretary of Health and Human Services to identify reasonable and necessary activities that do not constitute information blocking. ONC has identified, through the proposed rule, seven categories of practices that would be reasonable and necessary provided certain conditions are met. These exceptions to the information blocking definition support seamless and secure access, exchange, and use of EHI.
The seven proposed exceptions to the information blocking definition are intended to:
- Protect patient safety [PDF – 160 KB];
- Promote the privacy of EHI [PDF - 164 KB];
- Promote the security of EHI [PDF – 235 KB];
- Allow for the recovery of costs reasonably incurred [PDF- 179 KB];
- Excuse an actor from responding to requests that are infeasible [PDF - 149 KB];
- Permit the licensing of interoperability elements on reasonable and non-discriminatory terms [PDF – 20 6KB]; and
- Allow actors to make health IT temporarily unavailable for maintenance or improvements that benefit the overall performance and usability of health IT [PDF -. 143 KB]
To qualify for any of these exceptions, a regulated actor (health care provider, health IT developer, or health information exchange or health information network) would, for each relevant practice and at all relevant times, have to satisfy all of the applicable conditions of the exception.
If the actions of a regulated actor satisfy one or more exception, the actions would not be treated as information blocking and the actor would not be subject to civil penalties and other disincentives under the law.
What are the potential penalties and disincentives for information blocking?
Section 4004 of the Cures Act identifies potential penalties and disincentives for information blocking:
- Health IT developers, health information networks, and health information exchanges that the Inspector General, following an investigation, determines to have committed information blocking shall be subject to a civil monetary penalty determined by the Secretary of Health and Human Services for all such violations identified through such investigation, which may not exceed $1,000,000 per violation. Such determination shall take into account factors such as the nature and extent of the information blocking and harm resulting from such information blocking, including, where applicable, the number of patients affected, the number of providers affected, and the number of days the information blocking persisted.
- Health care providers determined by the Inspector General to have committed information blocking shall be referred to the appropriate agency to be subject to appropriate disincentives using authorities under applicable Federal law, as the Secretary of Health and Human Services sets forth through notice and comment rulemaking.
In its recent proposed rule, ONC included a Request for Information (RFI) regarding disincentives for health care providers.
Information blocking complaints can be submitted through the online Health IT Complaint Form.
As specified by the Cures Act, information blocking claims and information received by ONC in connection with a claim or suggestion of information blocking are generally protected from disclosure under the Freedom of Information Act.
We will review your complaint under ONC’s available authorities. Depending on the nature of your claim, we may contact you for additional information or, to the extent necessary and permitted by law, share the information you provided with other appropriate government agencies, such as the HHS Office of Inspector General.
We request input from the public in our proposed rule on the best way to implement a standardized process for the public to submit reports on claims of information blocking that will include the appropriate information to best support the investigation of such complaints. We encourage the public to comment through the rulemaking process.