Health Privacy

On June 19, 2025, the U.S. District Court for the Northern District of Texas vacated the majority of the Biden Administration rule (the “2024 Rule”) modifying the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”) under the Health Insurance Portability and Accountability Act (“HIPAA”) regarding protected health information (“PHI”) concerning reproductive health.  As discussed in further detail in our previous blog post, the 2024 Rule “limit[ed] the circumstances in which provisions of the Privacy Rule permit the use or disclosure of an individual’s PHI about reproductive health care for certain non-health care purposes.” Continue Reading District Court Enjoins Privacy Rule Modifications Regarding Reproductive Health Care

This blog was prepared in collaboration with, and was originally published by, the UK BioIndustry Association, here. We are grateful to the UK BioIndustry Association for collaborating on this blog, and for the opportunity to post it here.

What are the UK’s plans to reform data protection law?

After an extended period of legislative back and forth, the Data (Use and Access) Bill has now received Royal Assent, becoming the Data (Use and Access) Act (we will therefore refer to it as the “Act” in this blog). The Act addresses various matters related to the use of data, and will to an extent distinguish the UK’s approach to data protection from that set out in the EU’s General Data Protection Regulation (“GDPR”). The European Commission will, therefore, assess whether these changes warrant stripping the UK of its adequacy status for data transfers, with a decision due by 27 December 2025. While the Commission is unlikely to withdraw its finding of adequacy, it is possible that a challenge to this finding could be brought before the Court of Justice of the EU, which could reach a different conclusion.

In summary, the Act is not a complete overhaul of data protection law in the UK; instead, it is more a package of targeted amendments. Of the changes most relevant to biotechs, the most significant is the more permissive regime for the use of personal data for scientific research – although, companies must still meet a number of requirements to fall within scope. More significant changes may take place in the future, as key parts of the Act enable the UK Government to pass secondary legislation in areas that may be relevant to biotechs.Continue Reading The UK’s new Data Legislation – What does it mean for the Life Science sector?

Since the beginning of 2025, there have been a flurry of bills introduced at the state and federal level related to genetic privacy, which follows a similar trend over the past several years.  These bills have focused on a range of issues, including general genetic privacy, national security implications of “foreign adversaries” accessing genetic information, the privacy practices of direct-to-consumer (“DTC”) genetic testing companies, and the transfer of genetic data as part of bankruptcy proceedings, among others.  We summarize a subset of such bills moving through state and federal legislatures below.Continue Reading Multiple States Enact Genetic Privacy Legislation in a Busy Start to 2025

On January 22, the New York state legislature passed the New York Health Information Privacy Act (S929 / A2141) (“NYHIP”). If signed into law, NYHIP would join Washington and Nevada in a growing trend of states regulating consumer health information. Though NYHIP contains many similarities with laws in Washington and Nevada, there are a few unique provisions, as discussed below. Among them, NYHIP applies to “Regulated Health Information” or “RHI” that is defined as “any information that is reasonably linkable to an individual, or a device, and is collected or processed in connection with the physical or mental health of an individual.” Unlike the health privacy laws in Washington and Nevada, NYHIP does not provide an inclusive list of health data.

NYHIP would require regulated entities to obtain a “valid authorization” prior to processing RHI unless such processing is “strictly necessary” for certain enumerated purposes, including providing a product or service requested by the individual or certain limited internal business operations. NYHIP does not clarify what it means for a processing activity to be considered “strictly necessary.”

Where such an authorization is required, a valid authorization must, among other requirements: 

  • Be made at least twenty-four (24) hours after an individual creates an account or first uses the requested product or service; and
  • If multiple categories of processing are involved, provide an ability to “provide/withhold” authorization for each category separately.

Continue Reading New York Legislature Passes Health Privacy Act

On January 6, 2025, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) issued a notice of proposed rulemaking (the “proposed rule”), which proposes a number of significant updates to the HIPAA Security Rule.  According to OCR’s announcement, the proposed rule seeks to “improve cybersecurity and better protect the U.S. health care system from a growing number of cyberattacks” and “better align the Security Rule with modern best practices in cybersecurity.” The preamble states that the proposed rule seeks to address common areas of non-compliance with the Security Rule identified by OCR in its recent investigations, as well as build on recommendations from the National Committee on Vital Health Statistics and guidelines and best practices recommended by other parts of the government, such as the Cybersecurity and Infrastructure Security Agency (CISA) and the National Institute of Standards and Technology (NIST).

Below, we provide a brief summary of the proposed changes. The proposed rule is open for comment until March 7, 2025.
Continue Reading HHS Issues Notice of Proposed Rulemaking to Update the HIPAA Security Rule

On September 26, 2024, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS OCR”) announced that it had settled its cybersecurity investigation with Cascade Eye and Skin Centers, P.C. (“Cascade”), a privately-owned health care provider in Washington.  For background, HHS OCR is responsible for administering and enforcing the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations, which include the HIPAA Privacy, Security, and Breach Notification Rules (collectively, “HIPAA”).  Among other things, HIPAA requires that regulated entities take steps to protect the privacy and security of patients’ protected health information (“PHI”).Continue Reading HHS OCR Settles Ransomware Cybersecurity Investigation for $250,000

On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog…

Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices

On May 16, 2024, the CNIL launched a public consultation on all of its health data standards.  Interested stakeholders are encouraged to participate by completing a questionnaire (available in French here) by July 12, 2024.

French law has specific requirements for the processing of health data.  In particular, it…

Continue Reading CNIL Opens Public Consultation on Its Standards for Processing Health Data