FDA has issued two Federal Register notices in under two weeks that seek comments on updates to FDA data standards.
Continue Reading FDA Requests Comments on Substantial Proposed Changes to Data Standards
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 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 DevicesFTC Issues Final Rule to Expand Scope of the Health Breach Notification Rule
On Friday, April 26, 2024, the Federal Trade Commission (“FTC”) voted 3-2 to issue a final rule (the “final rule”) that expands the scope of the Health Breach Notification Rule (“HBNR”) to apply to health apps and similar technologies and broadens what constitutes a breach of security, among other updates. We previously covered the proposed rule, which was issued on May 18, 2023.Continue Reading FTC Issues Final Rule to Expand Scope of the Health Breach Notification Rule
HHS Publishes Final Rule to Align Part 2 and HIPAA
On February 16, 2024, the U.S. Department of Health and Human Services (“HHS”) published a final rule to amend the Confidentiality of Substance Use Disorder (“SUD”) Patient Records regulations (“Part 2”) to more closely align Part 2 with the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”) as required by Section 3221 of the 2020 Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”). We previously covered the proposed rule (hereinafter, “the NPRM”), which was issued on December 2, 2022.
The final rule, issued through the Office for Civil Rights (“OCR”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”), increases alignment between certain Part 2 requirements and HIPAA and it clarifies certain existing Part 2 permissions and restrictions to improve the ability of entities to use and disclose Part 2 records. According to HHS, this final rule will decrease burdens on patients and providers, improve coordination of care and access to care and treatment, and protect the confidentiality of treatment records.Continue Reading HHS Publishes Final Rule to Align Part 2 and HIPAA
California Enacts Amendments to the CMIA
On September 27, 2023, Governor Newsom signed AB 254 and AB 352, which both amend the California Confidentiality of Medical Information Act (“CMIA”). Specifically, AB 254 expands the scope of the CMIA to expressly cover reproductive or sexual health services that are delivered through digital health solutions and the associated health information generated from these services. AB 352 imposes new requirements on how electronic health record (“EHR”) systems must store medical information related to gender affirming care, abortion and related services, and contraception and the ability of providers of health care, health care service plans, contractors, or employers to disclose such information.Continue Reading California Enacts Amendments to the CMIA
FTC and HHS Announce Updated Health Privacy Publication
On September 15, the Federal Trade Commission (“FTC”) and U.S. Department of Health and Human Services (“HHS”) announced an updated joint publication describing the privacy and security laws and rules that impact consumer health data. Specifically, the “Collecting, Using, or Sharing Consumer Health Information? Look to HIPAA, the FTC Act, and the Health Breach Notification Rule” guidance provides an overview of the Health Insurance Portability and Accountability Act, as amended, and the implementing regulations issued by HHS (collectively “HIPAA”); the FTC Act; and the FTC’s Health Breach Notification Rule (“HBNR”) and how they may apply to businesses. This joint guidance follows a recent surge of FTC enforcement in the health privacy space. We offer a high level summary of the requirements flagged by the guidance.Continue Reading FTC and HHS Announce Updated Health Privacy Publication
NHS Data Partnerships Guide – unlocking the benefits of data partnerships
The NHS has issued guidance on effective data partnerships, this blog summarises key terms for parties looking to collaborate on data driven projects with the NHS.
Continue Reading NHS Data Partnerships Guide – unlocking the benefits of data partnerships
EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle
Hot on the heels of recent announcements from the U.S. Food and Drug Administration (see our prior blogs here), the European Medicines Agency (“EMA”) has joined the conversation on the use of Artificial Intelligence (“AI”) and Machine Learning (“ML”) technologies in the medicinal product lifecycle.
AI and ML have
Continue Reading EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle
FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development
On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”). This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug
Continue Reading FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development5 Reasons Digital Solutions for Women+ Health Will Grow in 2023
Innovative digital solutions intended to address health issues typically experienced by women have been an area of increased focus. Ranging from reproductive-related mobile applications to AI-enabled breast cancer screening devices, digital solutions for women+ health show promise to serve an enormous market with medical needs that have often failed to
Continue Reading 5 Reasons Digital Solutions for Women+ Health Will Grow in 2023