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 Devices5 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
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Change is Coming for Software and AI Medical Devices in the UK
The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”). On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as
Continue Reading Change is Coming for Software and AI Medical Devices in the UKOIG Issues Advisory Opinion on Digital Program for the Treatment of Substance Use Disorders
On March 2, 2022, the Office of Inspector General (“OIG”) for the Department of Health and Human Services (“HHS”) posted an advisory opinion concluding that a digital program for the treatment of substance use disorders would raise minimal fraud and abuse risk. OIG advisory opinions address the application of certain
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FTC Adopts Policy Statement on Privacy Breaches by Health Apps and Connected Devices
On September 15, the Federal Trade Commission (“FTC”) adopted, on a 3-2 party-line vote, a policy statement that takes a broad view of which health apps and connected devices are subject to the FTC’s Health Breach Notification Rule (the “Rule”) and what triggers the Rule’s notification requirement.
The Rule was promulgated in 2009 under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act. Under the Rule, vendors of personal health record that are not otherwise regulated under the Health Insurance Portability and Accountability Act (“HIPAA”) are required to notify individuals, the FTC, and, in some cases, the media following a breach involving unsecured identifiable health information. 16 C.F.R. §§ 318.3, 318.5. Third-party service providers also are required to notify covered vendors of any breach. 16 C.F.R. § 318.3.Continue Reading FTC Adopts Policy Statement on Privacy Breaches by Health Apps and Connected Devices
Proposed Bill Would Expand the Scope of the CMIA
Legislation that would amend California’s Confidentiality of Medical Information Act (“CMIA”) is working its way through California’s Senate and passed in the Senate Health Committee earlier this week. The proposed bill passed in the state’s Assembly back in April. Introduced by Democratic California Assemblymember Edwin Chau, who sits on the Privacy and Consumer Protection Committee, the proposed legislation (AB 1436) expands the definition of “provider of health care.” Under the CMIA, providers of health care are subject to various obligations, including provisions that restrict the disclosure of medical information without a prior valid authorization, subject to certain exceptions.
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FDA Releases AI Action Plan
FDA has long recognized the significant potential of artificial intelligence- and machine learning- (AI/ML-) based software as a medical device (SaMD) to transform health care as well as the unique challenges presented by AI/ML-based software under the Agency’s traditional medical device regulatory framework. On January 12, 2021, FDA issued the
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HHS Launches New “Health Apps” Website to Highlight HIPAA Guidance for Mobile Health Applications
On September 2, 2020, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced a new “Health Apps” feature on the HHS.gov website. The new website, which replaces the OCR’s Health App Developer Portal, highlights existing guidance for mobile health (“mHealth”) apps regarding the Health
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The Potential Benefits of Digital Health Technology in Managing COVID-19
The COVID-19 crisis is demonstrating the potential of digital health technology to manage some of our greatest public health challenges. The White House Office of Science and Technology Policy has issued a call to action for technology companies to help the science community answer high-priority scientific questions related to COVID-19.
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Digital Health Alert: Product Liability Considerations for COVID-19-Related Solutions
Product liability considerations are not likely the first concerns that spring to mind for the many companies working to develop digital health countermeasures and other products related to COVID-19. Yet even while putting together solutions on an accelerated timeline, there are some straightforward actions that companies can take that may
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