HIMSS and the Healthcare Leadership Council have led 28 organizations in asking the Department of Health and Human Services (HHS) Secretary Xavier Becerra for more specific and granular guidance on implementation of the 21st Century Cures Act Interoperability and Information Blocking Regulations.
Significant knowledge gaps still exist for providers, developers and health information networks/health information exchanges on implementation and enforcement of information blocking regulations. In a letter to Becerra sent Aug. 18, healthcare organizations asked for clarity on information blocking to better prepare and advise their communities on how to implement the provisions.
HIMSS and these groups want to collaborate across HHS to create a culture of learning around information sharing to ensure that health data is flowing across the entire ecosystem. The organizations support Micky Tripathi, U.S. National Coordinator for Health Information Technology, and the work occurring across the Office of the National Coordinator for Health Information Technology (ONC) to embrace the concept of information sharing.
The organizations recommended HHS take several steps.
The groups asked for detailed guidance on the foundational concepts underpinning information sharing. Included with the letter is an appendix that has the foundational questions that the organizations are receiving from their providers, members, clients and patients to gain clarity on expectations and requirements. Some of the key foundational concepts that need clarity include: What are good information sharing practices and how should they be implemented?; What actions can regulated actors undertake to demonstrate good intent for information sharing?; What constitutes a “request” for information sharing?
The groups encouraged HHS to provide scenario-based FAQs that give a greater degree of specificity and granularity than is currently covered on ONC’s website. The organizations believe that if HHS develops FAQs based on scenarios, individual stakeholders would be able to determine similarities with their own cases and adjust practices accordingly. The groups have identified several ambiguities with implementing the Information Blocking Exceptions that would be well-served by scenario-based FAQs. For example, there are instances where multiple exceptions could apply to particular questions. The community needs more information to ensure that stakeholders are complying with regulatory requirements.
HHS should provide information sharing technical assistance to regulated actors as well as the wider community to help the community comply with the regulations. As an example, the letter highlights that since 2003, the HHS Office for Civil Rights (OCR) has been using technical assistance to help covered entities and business associates come into compliance with the Health Insurance Portability and Accountability Act (HIPAA) before imposing penalties or requiring corrective action plans (CAPs) to resolve violations of HIPAA. The letter signers want HHS to provide technical assistance in recognition of good faith information sharing efforts similar to OCR before engaging in enforcement actions. They believe this form of assistance will provide a greater degree of transparency into how HHS is approaching compliance, which will increase community-wide understanding of information sharing.
As ONC and the HHS Office of Inspector General (OIG) release more granular and specific guidance on good information sharing practices and use case/scenario-based FAQs, the organizations encourage HHS to use the full extent of its communications capabilities to publicize this new information. For example, ONC should use its newsletters and website to notify the public when new information is released and consider a dedicated newsletter focused on implementing information sharing that supplies more information and context about the Information Blocking Exceptions or how HHS is interpreting the actions of regulated actors.
The groups thanked HHS for helping to advance health data exchange and interoperability. The 28 organizations on the letter also offered to act as a trusted resource to help establish a culture of learning around the implementation of Information Blocking Regulations.
The organizations that signed the letter include AdventHealth, Alliance for Nursing Informatics, American Academy of Family Physicians, American Academy of Neurology, American Heart Association, American Health Information Management Association, American Medical Informatics Association, Ascension, Civitas Networks for Health, College of Healthcare Information Management Executives, Connected Health Initiative, Consortium for State and Regional Interoperability, Contexture, CyncHealth, Nebraska & Iowa, eHealth Exchange, Epic, Executives for Health Innovation, Healthcare Information and Management Systems Society (HIMSS), HIMSS Electronics Health Record Association, HIMSS New York State Chapter, Healthcare Leadership Council, Indiana Health Information Exchange, Marshfield Clinic Health System, Mayo Clinic, Medical Group Management Association, OCHIN, Partnership to Empower Physician-Led Care, and Premier, Inc.
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