Health Law Advisor

On October 18, 2023, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”), which is tasked with enforcing the Health Insurance Portability and Accountability Act (“HIPAA”), issued two new guidance documents pertaining to privacy and security risks associated with the use of telehealth services. One guidance document, entitled “Educating Patients about Privacy and Security Risks to Protected Health Information when Using Remote Communication Technologies for Telehealth,” is aimed at health care providers (the ...

On April 11, 2023, U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced its plan for termination of the existing notifications of enforcement discretion related to the expiration of the COVID-19 public health emergency (PHE) on May 11, 2023. 

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.

The past several years have proven difficult for healthcare entities due to increasing cybersecurity threats, breaches and regulatory enforcement. Following these trends, on April 6, 2022, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a Request for Information (RFI) soliciting public comment on how regulated entities are voluntarily implementing security practices under the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act) and also seeking public input on sharing funds collected through enforcement with individuals who are harmed by Health Insurance Portability and Accountability Act of 1996 (HIPAA) rule violations.

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently submitted two reports to Congress setting forth the HIPAA breaches and complaints reported to OCR during calendar year 2020 as well as the enforcement actions taken by OCR in response to those reports. HIPAA covered entities should be aware of the trends identified in these reports and should examine their own compliance in these areas.

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 ...

On March 17, 2020, the Office for Civil Rights’ (“OCR”) announced that—for the duration of the COVID-19 emergency—it would exercise enforcement discretion and waive any potential penalties for HIPAA violations relating to health care providers’ use of “everyday communications technologies” in the provision of services via telehealth (the “HIPAA Waiver”). This move has resulted in a drastic increase in the number of telehealth encounters. The HIPAA Waiver has enabled many providers to immediately leverage these technologies to render services via telehealth for the first time, without the need to expend significant resources to quickly ramp up a HIPAA-compliant telehealth platform. A summary of the HIPAA Waiver can be found in a recent blog post. While the HIPAA Waiver applies only temporarily, it is likely that the increased reliance on telehealth evidenced over the past three months is here to stay.

The COVID-19 pandemic’s impact on the regulatory landscape of telehealth was the topic of a June 17, 2020 hearing before the Senate Health, Education, Labor & Pensions Committee.  As Chairman Lamar Alexander acknowledged during his opening statement, the health care sector and government “have been forced to cram 10 years’ worth of telehealth experience into just the past three months.” Indeed, this “cramming” has resulted in thirty-one temporary changes to telehealth policy at the federal level. Of these temporary changes, Chairman Alexander included the OCR enforcement discretion / HIPAA waiver as one of the three changes he considers most important. However, of the three changes the Chairman views as most important, he declined to include the enforcement discretion in the temporary changes he believes should be made permanent, and instead called upon his colleagues to consider whether to extend the HIPAA waiver.[1]

On January 28, 2020, the Department of Health & Human Services (“HHS”) Office for Civil Rights (“OCR”) addressed a federal court’s January 23rd invalidation of certain provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) rule relating to the third-party requests for patient records. In Ciox Health, LLC v. Azar,[1] the court invalidated the 2013 Omnibus Rule’s mandate that all protected health information (“PHI”) maintained in any format (not just that in the electronic health record) by a covered entity be delivered to third parties at the request of an individual, as well as the 2016 limitation on fees that can be charged to third parties for copies of protected health information (“PHI”).

As enacted, HIPAA’s Privacy Rule limits what covered entities (or business associates acting on behalf of covered entities)[2] may charge an “individual” requesting a copy of their medical record to a “reasonable, cost-based fee”[3] (the “Patient Rate”). The Privacy Rule did not, however, place limitations on the fees that can be charged to other requestors of this information, such as other covered entities that need copies of the records for treatment purposes or for disclosures to attorneys or other third parties.  In order for some of these third parties to obtain the records, the patient would have to provide the covered entity with a valid HIPAA authorization.  

On December 14, 2018 the Department of Health and Human Services, Office for Civil Rights (“OCR”) formally issued a Request For Information (“RFI”) seeking public input on “ways to modify the HIPAA Rules to remove regulatory obstacles and decrease regulatory burdens in order to facilitate efficient care coordination and/or case management and to promote the transformation to value-based healthcare, while preserving the privacy and security of PHI.”  OCR is seeking comments for a series of 54 different specific questions (many with additional subparts ...

On October 16, 2018 the Department of Health and Human Services Office for Civil Rights (“OCR”) and the Office of the National Coordinator for Health Information Technology (“ONC”) announced an update to their previously provided Security Risk Assessment Tool.  According to ONC and OCR, the “tool is designed to help healthcare providers conduct a security risk assessment” as required under the HIPAA Security Rule.  ONC states that the updated tool includes additional features such as:

• Enhanced user interface
• Modular workflow
• Custom assessment logic
• Progress ...

Last week, the federal Department of Health and Human Services (HHS) made two announcements aimed at providing additional protections for health care workers who object to providing services on moral or religious grounds.

On January 18, 2018, HHS announced the formation of a new Conscience and Religious Freedom Division in the HHS Office for Civil Rights (OCR).  The stated goal of the new division is to “restore federal enforcement of our nation’s laws that protect the fundamental and unalienable rights of conscience and religious freedom.”

The next day, on January 19, HHS ...

Last week's "WannaCry" worldwide Ransomware attack was particularly targeted against international health organizations. Though the attack was thwarted not without a little good luck and less financial loss that might have been predicted, it unsurprisingly triggered responses from U.S. government agencies including the Department of Homeland Security (DHS) and, with specific reference to health care providers, the Office of Civil Rights (OCR) of the Department of Health & Human Services (HHS). It also is no surprise that these government agencies took a carrot and stick ...

Executive Order Delay Trumps Administration Policy Development

President Trump's first hundred days did not produce the event that most people in the cybersecurity community expected – a Presidential Executive Order supplanting or supplementing the Obama administration's cyber policy – but that doesn't mean that this period has been uneventful, particularly for those in the health care space.

The events of the period have cautioned us not to look for an imminent Executive Order. While White House cybersecurity coordinator Robert Joyce recently stated that a forthcoming ...

The U.S. Department of Health and Human Services, Office of Civil Rights ("OCR"), the agency tasked with enforcing the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), recently announced that it will redouble its efforts to investigate smaller breaches of Protected Health Information ("PHI") that affect fewer than five-hundred (500) individuals.

It has been widely known that OCR opens an investigation for every breach affecting more than 500 individuals; this announcement describes OCR's new initiative to investigate smaller breaches as well.  OCR ...

By Patricia Wagner, Ali Lakhani and Jonathan Hoerner

On May 20, 2014, the Secretary of the Department of Health and Human Services (HHS) submitted the agency's Annual Report to Congress on Breaches of Unsecured Protected Health Information for Calendar Years 2011 and 2012 ("Breach Report"). This report provides valuable insight for healthcare entities regarding their data security and enforcement priorities.

Section 13402(i) of the Health Information Technology for Economic and Clinical Health Act (HITECH) requires the Secretary of Health and Human Services ...

On May 20, 2014, the Secretary of the Department of Health and Human Services (HHS) submitted the agency’s Annual Report to Congress on Breaches of Unsecured Protected Health Information for Calendar Years 2011 and 2012 (“Breach Report”). This report provides valuable insight for healthcare entities regarding their data security and enforcement priorities.

Section 13402(i) of the Health Information Technology for Economic and Clinical Health Act (HITECH) requires the Secretary of Health and Human Services to prepare an annual report regarding the number and nature of ...

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule provides standards for the use and disclosure of "individually identifiable health information," dubbed protected health information, or PHI.  PHI is information, including demographic information, that relates to an individual's physical or mental health, the provision of health care to the individual, or payment for the provision of health care to the individual.  Such information constitutes PHI if it identifies the individual or if there is a reasonable basis to believe it can be ...

By Ross K. Friedberg and Ophir Stemmer

This year we’ve seen a continuation of the trend toward heightened regulation and enforcement of the privacy and security requirements under the Health Information Portability andAccountability Act (“HIPAA”) and under other state and federal health privacy laws. Although there have not been any significant changes to federal health privacy laws this year, federal enforcement activity continues to be strong.

This post provides a summary of the developments in privacy and security law throughout the past year; discusses the ...

For those healthcare employers that have been resting on your laurels and viewing through rose-colored glasses your entity’s HIPAA (Health Insurance Portability and Accountability Act of 1996) and HITECH (Health Information Technology for Economic and Clinical Health) compliance efforts, the time has come to thoroughly clean your glasses and prepare for increased Office of Civil Rights (“OCR”) enforcement actions.  Speaking at the recent National HIPAA Summit, the OCR’s Director, Leon Rodriguez, announced that the OCR intends to follow the Office of Inspector ...