Over the last decade, members of the medical and public health communities around the world have widely studied and acknowledged the impact of social determinants of health (SDOH)—the conditions in the environments where people live, learn, work, play, and age—on a wide range of health, functioning, and quality-of-life-risks and outcomes.[1]  In the past year

This post was also written by Marquan Robertson, a Reed Smith summer associate. 

In 2019, the Department of Health and Human Services Office of Civil Rights (OCR) announced its Right of Access Initiative. The Right of Access Initiative realizes OCR’s commitment to ensuring the aggressive enforcement of patients’ rights to receive copies of their medical

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), is the latest federal agency to jump on the HHS rulemaking bandwagon issuing a Notice of Proposed Rulemaking (NPRM) on December 10, 2020, that proposes pivotal changes

Just two business days before the first of many critical components of the new 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) were set to take effect, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC)

Even amidst the chaos of a global pandemic, this year multiple U.S. Department of Health and Human Services (HHS) agencies have dialed in on promoting and enforcing patients’ rights to access their health information.

In just the past month, HHS’ Office for Civil Rights (OCR), the agency that enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA), settled five costly investigations with HIPAA-regulated parties for potential violations of the HIPAA right of access provision.  Under HIPAA, individuals have a legal, enforceable right to view and obtain copies, upon request, of the information in their medical and other health records maintained by a HIPAA covered entity, typically a health care provider or health plan, with limited exception.  Individuals generally have a right to access this information for as long as the information is maintained by a covered entity, or by a business associate on behalf of a covered entity, regardless of the date the information was created, whether the information is maintained in paper or electronic systems onsite, remotely, or is archived, or where the information originated (e.g., whether the covered entity, another provider, or the patient).
Continue Reading Patient access to health information at the forefront of government initiatives and scrutiny

Following more than a month of silence from the U.S. Department of Health and Human Services (HHS) on the publication of its widely anticipated companion interoperability and information blocking final rules to the Federal Register, HHS’s Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS), in conjunction with the Office of the Inspector General (OIG), issued a joint statement announcing a policy of enforcement discretion to allow compliance flexibilities regarding the implementation of the final rules in response to the COVID-19 public health emergency.  The agencies indicated that they would continue to monitor the developing public health emergency to determine if further action is necessary.

OIG Proposed Rule

OIG issued an unpublished proposed rule amending the civil monetary penalty (CMP) regulations to include new CMP authorities for violations of ONC’s information blocking final rule.  OIG is seeking comment on when information blocking enforcement should begin, but has proposed to delay enforcement until 60 days after publication of the OIG’s final rule.  At a minimum, enforcement would not begin sooner than the compliance date for the ONC final rule established in 45 CFR § 171.101(b), which is November 2, 2020.

CMS Final Rule

CMS announced that the agency is extending the implementation timeline by an additional six months for certain components of its interoperability rule, including, for example, the admission, discharge, and transfer notification Conditions of Participation (CoPs).  In the unpublished version of CMS’ final rule, the agency initially stated these CoPs would be effective six months after the publication of the final rule.  Now, they will be effective one year after the final rule is published in the Federal Register – a date that is still to be determined.  CMS will implement and enforce other policies contained in the final rule on schedule.

ONC Final Rule

Earlier this week, ONC reissued the unpublished version of its final rule, which is now set for publication on May 1, 2020, with an effective date of June 30, 2020.  While the publication date triggers multiple compliance dates for various components of the interoperability and information blocking provisions (set at 60 days, 6 months, and 24 months following publication), the agency is changing that timeline for certain requirements in light of the COVID-19 crisis.  ONC has published new enforcement discretion dates and timeframes on its website.  We have summarized some key changes to the ONC final rule compliance timeline below.

Continue Reading HHS Delays Compliance for Sweeping Interoperability and Information Blocking Rules

The U.S. Department of Health and Human Services (HHS) issued eagerly anticipated and hotly debated companion interoperability and information blocking final rules that are expected to transform the way in which certain health care providers, health information technology (IT) developers, and health plans share patient information.  The two rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), implement interoperability and patient access provisions of the 21st Century Cures Act (Cures Act) and support the MyHealthEData initiative, designed to allow patients to access their health claims information electronically through the application of their choosing.

Major provisions of each final rule are highlighted below. Note that the final rules have not yet been formally submitted to the Federal Register, so some of the precise effective dates are still to be determined.

ONC Final Rule

For Providers, Health Information Networks or Exchanges, and Health IT Developers

  • Prohibition on Information Blocking. Effective six months following the publication of the final rule, health care providers, health IT developers of certified health IT, and health information exchanges and networks, are banned from “information blocking.”  Information blocking is defined in the rule as engaging in a practice that is likely to interfere with, prevent, or materially discourage access, exchange or use of electronic health information (EHI) and, if (a) conducted by a health IT developer or health information network or exchange, such developer, network or exchange knows, or should know or (b) if conducted by a health care provider, such provider knows – the practice is likely to interfere with, prevent, or materially discourage access, exchange, or use of EHI.
    • EHI means electronic protected health information (EPHI) as the term is defined for HIPAA, to the extent that it would be included in a designated record set, with certain exceptions, regardless of whether the group of records are used or maintained by or for a HIPAA covered entity. This EHI definition will be effective 24 months after the publication of the final rule.  In the interim, for purposes of information blocking, EHI is limited to the EHI identified by the data elements represented in the U.S. Core Data for Interoperability (USCDI) standard.
    • Health care providers include health care facilities, entities, practitioners, and clinicians listed in the Public Health Service Act. ONC did not expand the definition of health care provider in the Final Rule to cover all individuals and entities covered by HIPAA.  However, the final rule leaves this door open by giving the Secretary of HHS discretion to expand the definition of health care provider to any other category the Secretary deems appropriate by future rulemaking.
  • Examples of Information Blocking. According to ONC, information blocking practices could involve, among other things: formal restrictions in contract or licensing terms; limiting or restricting the interoperability of health IT through organizational policies or procedures or other EHI or health IT documentation; information restrictions, such as if an entity simply refuses to exchange or facilitate access to EHI as a general practice or in isolated cases; or use of certain technological measures that limit EHI exchange.
  • Information Blocking Exceptions. The final rule identifies eight activities as exceptions to information blocking.  According to ONC, the exceptions apply to certain activities that are likely to interfere with, prevent, or materially discourage the access, exchange, or use of EHI, but that would be reasonable and necessary if certain conditions are met.  Each exception falls into one of two categories: (i) exceptions that involve not fulfilling requests to access, exchange, or use EHI; and (ii) exceptions that involve procedures for fulfilling requests to access, exchange, or use EHI.
  • Penalties for Information Blocking. Consistent with the Cures Act, ONC’s information blocking prohibition seeks to deter information blocking through penalties that differ based on the actor.  Health IT developers and health information networks and exchanges are subject to civil money penalties capped at $1 million per violation, while health care providers who violate the information blocking provisions may face unspecified disincentives for violations, to be determined by the appropriate HHS department or agency in subsequent rulemaking.


Continue Reading HHS Finalizes Healthcare Interoperability and Information Blocking Rules