Information Blocking

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Industry stakeholders have been eagerly waiting for the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Secretary of HHS to provide more clarity on federal information blocking enforcement rules since the Office of the National Coordinator for Health Information Technology (ONC) issued its final information blocking rules in 2020.[i] Continue Reading HHS OIG Publishes Eagerly-Anticipated Federal Information Blocking Enforcement Final Rule

Under the 21st Century Cures Act information blocking requirements and the regulations promulgated thereunder by the Office of the National Coordinator for Health IT (ONC) (the Information Blocking Rules), certain actors, such as healthcare providers and certain electronic health record developers (Actors), are prohibited from engaging in information blocking of electronic health information (EHI). Information blocking is defined, in part, as a practice that “[e]xcept as required by law or covered by an exception [to the information blocking regulations], is likely to interfere with access, exchange, or use of electronic health information.”[1] Put simply, the Information Blocking Rules generally prohibit any act or omission by an Actor that interferes with the access, exchange, or use of EHI, subject to enumerated exclusions and exceptions. Continue Reading Navigating Permissive State Laws in Light of the Federal Information Blocking Rules

On May 13, 2021, MITRE Corporation, a non-profit that provides engineering and technical guidance for the federal government, published a long-awaited report proposing a National Strategy for Digital Health (the “Report”).  The proposed strategy provides a framework and prescribes tangible action items in order to revolutionize the American healthcare system through digital tools and technology.  The underlying premise is that harnessing the power of research, data, and innovation can further shared goals and accomplish priority outcomes to transform not only the digital plane of the healthcare system, but every facet of modern American healthcare.
Continue Reading MITRE Corporation Outlines a Proposal for a Digital Health Revolution in New Report

Access to healthcare information (or lack thereof) has always been touted as one of the key factors/necessities to realizing the promise of technology in the delivery of healthcare. Despite various legislative, judicial, patient and industry initiatives, access continues to be a challenge due to a variety of competitive practices and lack of capabilities. Consider the following events and whether they signal real progress:

  1. In a September 9, 2019 Press Release issued by the United States Department of Health & Human Services – Office of Civil Rights (“OCR”), the OCR announced that it had taken action against Bayfront Health St. Petersburg (“Bayfront”), an academic medical center in St. Petersburg, Florida, to enforce the Health Insurance Portability and Accountability Act (“HIPAA”) protections that guarantee every patient the right to receive copies of his/her medical records promptly and without being overcharged. The enforcement action against Bayfront (which includes the assessment of an $85,000 fine against Bayfront and the imposition of a “Resolution Agreement” between OCR and Bayfront) is notable as the OCR’s first enforcement action under the OCR’s “Right of Access Initiative” – a program designed to focus OCR resources on the enforcement of HIPAA’s right of access guarantees.
  2. On February 11, 2019, two offices of the US Department of Health and Human Services (“HHS”) — the Office of the National Coordinator for Health Information Technology (“ONC”) and the Centers for Medicare and Medicaid Services (“CMS”) – each released a proposed rule (ONC Proposed Rule; CMS Proposed Rule) (collectively, the “Proposed Rules”) aimed at enhancing the interoperability of electronic health record (“EHR”) systems and increasing patient access to electronic health information (“EHI”) as required by the 21st Century Cures Act.
  3. On September 23, 2019, seven major healthcare leadership groups, including the American Health Information Management Association (“AHIMA”) and the American Medical Association (AMA), sent a letter to Congress (the “AHIMA Letter”) critiquing the ONC Proposed Rule.

What is the link between the Bayfront case, the Proposed Rules, and the AHIMA letter? The link is commonly referred to as “Information Blocking.”
Continue Reading INFORMATION BLOCKING AND THE RIGHT TO ACCESS INITIATIVE: Why Patients Struggle to Obtain their Medical Records and what the Office of Civil Rights Intends to Do About It