Health Law Advisor

On August 5, 2024, the Office of the National Coordinator for Health Information Technology— now known as the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health IT (“ASTP/ONC”) within the U.S. Department of Health and Human Services (“HHS”)—issued a proposed rule titled “Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability” (the “HTI-2 Proposed Rule”), as part of its ongoing efforts to enhance health care interoperability and data sharing. The HTI-2 Proposed Rule builds on the January 2024 “Health Data, Technology, and Interoperability” final rule (the “HTI-1 Final Rule”). Comments on the HTI-2 Proposed Rule are due October 4.

Through the proposed changes, ASTP/ONC would (1) make sweeping changes to its Health Information Technology Certification Program (“HIT Certification Program”); (2) make revisions to the information blocking regulation, including implementing two new information blocking exceptions; and (3) codify and implement the statutory provisions regarding the Trusted Exchange Framework and Common Agreement (“TEFCA”) requirements.

New and Revised HIT Certification Criteria

The proposed changes in the HTI-2 Proposed Rule would significantly expand the scope of the HIT Certification Program to introduce additional functionality and new technology for developers of HIT used by health care providers and HIT that is intended to be used by payers and for public health agencies. The certification criteria introduced in HTI-2 for payers is the first time that the health IT certification program is being extended beyond the certified electronic health record (EHR) technology developers. Some notable changes include the following:

The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization to eliminate the federal constitutional right to abortion continues to alter the legal landscape across the country. On April 26, 2024, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published the “HIPAA Privacy Rule to Support Reproductive Health Care Privacy” (the “Final Rule”).

The Final Rule—amending the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance ...

On Monday, March 11, 2024, the Office of the National Coordinator for Health Information Technology’s (ONC) Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule went into effect. Among several elements of HTI-1, ONC promulgated “information blocking enhancements” which include new and updated definitions, as well as new and updated information blocking exceptions. Other sections of HTI-1 introduce algorithm transparency and replace “clinical decision support” ...

On July 1, 2024 the Center for Medicare and Medicaid Innovation (“CMMI”) will be inaugurating a new value-based payment model designed specifically to address the devastating impacts that a diagnosis of dementia^[1] or Alzheimer’s Disease[2] can have on a patient, their family, friends, and other caregivers who make up the patient’s circle of support. The Centers for Medicare and Medicaid Services (“CMS”) designed the Guiding an Improved Dementia Experience (“GUIDE”) model (the “Model”) for health care providers enrolled in Medicare Part B and that treat ...

Introduction

Following the Supreme Court decision in Dobbs v. Jackson Women’s Health Organization overturning Roe v. Wade, the federal government, pursuant to President Biden’s Executive Order (the EO) took several steps to protect reproductive health privacy, some of which we previously discussed here. Specifically, the EO called for agencies to protect “women’s fundamental right to make reproductive health decisions.” Shortly following issuance of the EO, the Biden Administration created its HHS Reproductive Healthcare Access Task Force, requiring all relevant federal agencies to draft measurable actions that they could undertake “to protect and bolster access to sexual and reproductive health care.”  

On December 1, 2022, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) published a bulletin warning that commonly used website technologies, including cookies, pixels, and session replay, may result in the impermissible disclosure of Protected Health Information (“PHI”) to third parties in violation of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The bulletin advises that “[r]egulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of Protected Health Information (“PHI”) to tracking technology vendors or any other violations of the HIPAA Rules.” The bulletin is issued amidst a wider national and international privacy landscape that is increasingly focused on regulating the collection and use of personal information through web-based technologies and software that may not be readily apparent to the user.

Only a few days remain before the enforcement delay that the Centers for Medicare & Medicaid Services (CMS) exercised due to COVID-19 will end and the agency will require certain payors to publish a Patient Access application programming interface (“API”) and a Provider Directory API under the requirements of the CMS Interoperability and Patient Access Final Rule. Starting on July 1, 2021, all health plans that offer Medicare Advantage, Medicaid and Children’s Health Insurance Program (CHIP) and most Qualified Health Plans offered through the Federally-facilitated ...

The roll out of the Office of the National Coordinator’s (ONC) 21^st Century Cures Act Interoperability and Information Blocking Rules is reminiscent of the way HIPAA has rolled out over the course of the past 25 years. As of May 1, 2021, Actors have been required to comply with the Information Blocking rules. However, it will take some time before all Actors know who they are and for complaints of Information Blocking to be determined to be actual instances of Information Blocking, by which time the penalties that have not yet been finalized may also need to be adjusted.

While ONC defined ...

On April 29, 2021, the Federal Communications Commission (FCC) will begin accepting applications for the second round of its COVID-19 Telehealth Program (the “Program”). However, the application filing window will only be open for a very short seven day period and will close on May 6, 2021. To give all applicants an equal opportunity to have their applications reviewed, the FCC announced that all applications filed during this period will be reviewed once the application filing window has closed.

Initially, in March 2020, Congress appropriated $200 million for the first round of the COVID-19 Telehealth Program funding under the CARES Act. An additional $249.95 million was provided to the FCC in December 2020, under the Consolidated Appropriations Act (CAA), to helping address inequities in access to health care service. The COVID-19 Telehealth Program was designed to help health care providers purchase telecommunications equipment, broadband connectivity, and other devices necessary for providing telehealth services to rural, low-income and underserved populations.

The Program is limited to nonprofit and public health care providers (47 U.S.C. § 254(h)(7)(B)) that fall within the following categories:

1. Post-secondary educational institutions offering health care instruction, teaching hospitals, and medical schools;
2. Community health centers or health centers providing health care to migrants;
3. Local health departments or agencies;
4. Community mental health centers;
5. Not-for-profit hospitals;
6. Rural health clinics;
7. Skilled nursing facilities; or
8. Consortia of health care providers consisting of one or more entities falling into one of the first seven categories.

As employers continue their efforts to safely bring employees back to the workplace, many have moved beyond initial pre-entry wellness checks or questionnaires and are considering technology solutions that monitor social distancing and conduct contact tracing in real-time. Along with introducing these enhanced capabilities, the question of the privacy and security of employee personally identifiable information (“PII”) and protected health information (“PHI”) continues to loom.

In order to isolate and contain the spread of COVID-19, one critical component of an ...

As consumerism in healthcare increases, companies and the individuals they serve are increasingly sharing data with third-party application developers that provide innovative ways to manage health and wellness, among numerous other products that leverage individuals’ identifiable health data.  As the third-party application space continues to expand and data sharing becomes more prevalent, it is critical that such data sharing is done in a responsible manner and in accordance with applicable privacy and security standards. Yet, complying with applicable standards requires striking the right balance between rules promoting interoperability vis-à-vis prohibiting information blocking vs. ensuring patient privacy is protected. This is especially difficult when data is sent to third party applications that remain largely unregulated from a privacy and security perspective.  Navigating this policy ‘tug of war’ will be critical for organizations to comply with the rules, but also maintain consumer confidence.

On July 7, the Court of Justice of the European Union (ECJ) invalidated the EU-US Privacy Shield framework in its ruling in Data Protection Commissioner v. Facebook Ireland and Maximillian Schrems (Case C-311/18). More than 5,000 organizations in the United States have certified their adherence to this framework, and have relied on it to receive personal data from organizations in the EU in compliance with the General Data Protection Regulation (GDPR) since 2016. The framework was a joint effort between the US Department of Commerce and the European Commission and Swiss Administration to provide companies on both sides of the Atlantic with a mechanism to comply with data protection requirements when transferring personal data from the European Union and Switzerland to the United States in support of transatlantic commerce. The Department of Commerce released the following statement:

The United States shares the values of rule of law and protection of our democracies with our partners in the European Union (EU).  Therefore, we are deeply disappointed that the Court of Justice of the European Union (“ECJ”) has invalidated the EU-U.S. Privacy Shield framework.  The United States is reviewing this outcome and the consequences and implications for more than 5,300 European and U.S. companies, representing millions of transatlantic jobs and over $7.1 trillion in commercial transactions.

The United States and the EU have a shared interest in protecting individual privacy and ensuring the continuity of commercial data transfers.  Uninterrupted data flows are essential to economic growth and innovation, for companies of all sizes and in every sector, which is particularly crucial now as both our economies recover from the effects of the COVID-19 pandemic.  This decision directly impacts both European companies doing business in the United States as well as American companies, of which over 70 percent are small and medium enterprises.  The United States will continue to work closely with the EU to find a mechanism to enable the essential unimpeded commercial transfer of data from the EU to the United States.

On April 21, 2020, the Drug Enforcement Administration (DEA) published a Request for Information (“RFI”) that reopened the comment period for an interim final rule that was published March 31, 2010 (75 FR 16236) (the “2010 IFR” or the “IFR”). The IFR is being revisited in response to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) mandate for the DEA to update the requirements for the biometric component of multifactor authentication with respect to electronic prescriptions of controlled substances. Prior to the 2010 IFR, the only way that controlled substances could be prescribed was in writing, on paper with a wet signature. The IFR was the first time that an electronic alternative was made available for prescribing controlled substances and the DEA leveraged the technologies that were available at the time to ensure that electronic prescribing applications could not be misused to divert controlled substances.

To that end, the DEA fashioned their regulations to include measures that ensure that the prescriber verifies that they are who they said they are and that they are authorized and have the appropriate credentials to prescribe the medications that are being ordered. In other words, in order for a prescriber to be granted access to the technologies that would create, sign and transmit prescriptions for controlled substances electronically, they have to be appropriately authenticated and credentialed. In addition to requiring identity proofing and logical access controls that relied on multi-factor authentication, credentialing had to be conducted by federally approved credential service providers (CSPs) or by certification authorities (CAs). The IFR also included requirements for audit trails, security event reporting and provisions that governed the signing and transmission of electronic prescriptions to ensure that there was a process to address and resolve transmission failures.

While the IFR contemplated using biometrics to identify and authenticate prescribers, those technologies were still developing and evolving in 2010. Recently, under the SUPPORT Act, Congress required the DEA to update its regulations to identify the biometric component of the multi-factor authentication used to identity proof prescribers. The DEA is looking to the health care provider community who are currently using e-prescribing applications to share their experiences, offer suggestions and recommend new approaches that will encourage broad adoption for e-prescribing for controlled substances while still meeting the DEA’s objectives of ensuring the security and accountability necessary to identify fraud and prevent diversion.