ONC Information Blocking Rule and its implications
21st Century Cures Act provided the regulatory framework for the Office of the National Coordinator for Health Information Technology (ONC) to enact the Information Blocking Rule. This rule puts patients in charge of their health records by fostering interoperability requirements that Health IT systems need to have in place to support seamless exchange of health information.
Putting the patient first in health technology enables the health care system to deliver:
- Transparency into the cost and outcomes of their care
- Competitive options in getting medical care
- Modern smartphone apps to provide them convenient access to their records
- An app economy that provides patients, physicians, hospitals, payers, and employers with innovation and choice
What is Information Blocking?
Information blocking is a practice by a health IT developer of certified health IT, health information network, health information exchange, or health care provider 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 access, exchange, or use of electronic health information (EHI).
Scope of the Rule
The scope of this rule applies to 3 important actors:
- Healthcare Providers
- Health Information Exchanges/Networks
- Health IT products/Certified Health IT
We will look into the aspects of the rule that healthcare providers will need to keep in mind when evaluating any requests for access to health information. Healthcare providers play a crucial role in this rule in that they should be able to share patient health information with patients and other actors upon request easily and inexpensively. The certification components of the rule enable providers and hospitals to take benefit of the Healthcare IT ecosystem by allowing a choice of apps that can interact with their certified Health IT systems to enable interoperability and support better patient care. There are situations wherein requests for information access cannot be fulfilled and the rule has provided appropriate safeguards for such situations. The rule also supports improvement to patient safety with use of Health IT systems by encouraging transparency around notification of patient safety issues within the Health IT system while also protecting the intellectual property rights of Health IT developers.
Scope of Information considered in Info Blocking Rule
The Information Blocking Rule applicability date is April 5, 2021. Starting this date, provisions of this rule apply to all actors. To promote interoperability and to offer a minimum acceptable standard with which Health IT systems can support information exchange, ONC has prescribed the USCDI (United States Core Data for Interoperability), which includes important clinical information about patients that needs to be included in any information access request response. USCDI serves as the scope of information or EHI with respect to information blocking until 10/05/2022. After this date, the scope of EHI expands to cover all aspects of the designated record set as defined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
What If you contribute to Info-Blocking?
If an actor participates in an activity or activities that constitute Information Blocking, they are subject to be investigated by the HHS Office of Inspector General and appropriate disincentives will be levied. Hence it is important to fully understand the scope of this rule and ensure that you have the processes in place to support the requirements of this regulation.
Exceptions available for Actors
Considering situations that may warrant unfulfillment of an information access request, ONC has defined eight exceptions that offer actors (i.e., health care providers, health IT developers, health information networks (HINs), and health information exchanges (HIEs)) certainty that, when their practices with respect to accessing, exchanging, or using EHI meet the conditions of one or more exceptions, such practices will not be considered information blocking. These exceptions fall into 2 categories:
- Exceptions that involve not fulfilling requests to access, exchange, or use EHI; and
- Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI
Exceptions that involve not fulfilling requests to access, exchange, or use EHI
- Preventing Harm Exception
- Privacy Exception
- Security Exception
- Infeasibility Exception (tighter deadline for compliance)
- Health IT performance Exception
Exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI
- Content and Manner Exception
- Fees Exception
- Licensing Exception
Recommendations to Healthcare Providers
The ONC Information Blocking Rule officially kicks off on April 5, 2021 and applies to healthcare providers. We recommend that you review the privacy and security policies of your practice to ensure that you are equipped to handle information access requests. We also recommend you carefully review the information blocking exceptions to ensure you are better prepared to exercise these options when appropriate.
Practice Fusion is prepared to support your health IT needs and is working diligently to address the requirements of the Information Blocking Rule, specifically the components that apply to certified Health IT products. Practice Fusion is planning to offer interoperability enhancements in the C-CDA (Consolidated Clinical Document Architecture) workflows by supporting USCDI data elements later this year. Practices can exchange health information pertinent to USCDI using the C-CDA format. We are also evaluating the requirements for API-based certification criteria and are prepared to support our practices with certified API capabilities before the regulatory deadline of December 2022.
Practice Fusion will be offering knowledge base articles related to the Information Blocking Rule as we improve our product experience, as well as articles regarding the Fast Healthcare Interoperability Resources (FHIR®) API standard and EHI exports. More details will be made available soon.
Dates to remember:
|April 5, 2021||Information Blocking Rule goes into effect||Review Security and Privacy policies and review the Information Blocking exceptions applicable|
|April 5, 2021 – October 5, 2022||Scope of Information/EHI is limited to USCDI||Practice Fusion will be supporting USCDI in the C-CDA format. Practice Fusion will be offering regular updates on improvements to APIs to support USCDI in 2021. Go to this link (knowledge base article guidance) for details on how to provide USCDI data elements to Information requestor.|
|Beyond October 6, 2022||Scope of EHI is broader (refer to definition of Designated Record Set)||Review your current process for fulfilling patient requested records an ensure that you are prepared to support the requirements of EHI. Practice Fusion will comply with certification compliance deadlines regarding use of APIs for information exchange and EHI Export capability to enable export of single patient record or bulk export of patient records ahead of the regulatory deadline prescribed by ONC and offer periodic updates to you through product improvements.|
|December 31, 2022||FHIR API made available to customers||Practice Fusion will meet certification compliance deadlines regarding use of HL7 FHIR API for information exchange.|
|December 31, 2023||EHI Export tool(s) made available to customers||Practice Fusion will meet certification compliance deadlines regarding use of EHI export capabilities to enable export of a single patient record or bulk export of patient records.|