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ONC Information Blocking Rule and its implications

Summary

21st Century Cures Act provided the regulatory framework for 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 deliver1:

  • 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:

  1. Healthcare Providers
  2. Health Information Exchanges/Networks
  3. Health IT products/Certified Health IT

We will look into the aspects of the rule that Health Care Providers2 will need to keep in mind when evaluating any requests for access to health Information. Healthcare Providers play a crucial role in this rule such that they should be able to share patient health information easily with patients and other actors upon request in an easy and inexpensive manner. The certification components of the rule enable providers and hospitals to take benefit of the Healthcare IT ecosystem by allowing choice of Apps that can interact with their certified Health IT systems to enable interoperability and support better patient care. There are situations wherein request 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

Information Blocking Rule applicability date is April 5,2021. Starting this date, provisions of this rule will 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 Electronic Health Information (EHI) with respect to Information Blocking until 10/05/2022. After this date, the scope of EHI expands to cover all aspects of designated record set3 as defined by HIPAA.

What If you contribute to Info-Blocking?

If an actor participated in activity/activities that constitutes Information Blocking, they are subject to be investigated by 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 which may warrant unfulfillment of 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 electronic health information (EHI) meet the conditions of one or more exceptions, such practices will not be considered information blocking.

  • 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

ONC Information Blocking rule officially kicks in on April 5,2021 and applies to Healthcare Providers and 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 to 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 Info Blocking Rule specifically the components that apply to certified Health IT products. Practice Fusion is planning to offer interoperability enhancements in the C-CDA 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 also be offering knowledge base articles related to Information Blocking Rule as we improve our product experience. To this effect, we are hosting a webinar on Information Blocking for our clients. More details will be made available soon.

Dates to remember:

Date Milestone Actions recommended
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.

References:

  1. https://www.healthit.gov/curesrule/overview/about-oncs-cures-act-final-rule
  2. https://www.healthit.gov/cures/sites/default/files/cures/2020-08/Health_Care_Provider_Definitions_v3.pdf
  3. https://www.law.cornell.edu/cfr/text/45/164.501 and https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html
  4. https://www.healthit.gov/cures/sites/default/files/cures/2020-10/Highlighted_Regulatory_Dates_All.pdf