Throughout September, the Department of Health and Human Services, Office for Civil Rights (“OCR”), announced eight different settlements to resolve a variety of alleged violations of the Privacy and Security Rules promulgated under the Health Insurance Portability and Accountability Act
Covington Digital Health
Developments and Trends in Digital Health, eHealth and Health IT
Covington Digital Health, published by Covington & Burling LLP, focuses on legal and regulatory developments at the intersection of digital health, biotechnology, and life sciences. The blog covers topics such as regulatory compliance for AI-enabled medical devices, data protection and privacy in clinical trials, FDA policies on digital therapeutics and health technology, and innovations in healthcare data interoperability. It also addresses emerging issues related to artificial intelligence in healthcare, real-world evidence generation, and the evolving regulatory landscape for digital health technologies. The blog serves as a resource for companies navigating complex legal frameworks in digital health and life sciences sectors.
Latest from Covington Digital Health - Page 10
California Legislature Adopts CCPA Exemption for Information Deidentified in Accordance with the HIPAA Privacy Rule
In a new post on the Covington Inside Privacy blog, our colleagues discuss the passage of California’s AB 713, a bill that creates a new healthcare-related exemption under the California Consumer Privacy Act of 2018 (“CCPA”) for certain information…
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…
FTC Provides Guidance on Use of AI and Algorithms
The FTC has recently provided new guidance on the use of AI and algorithms, including a blog post that focuses on the benefits and risks of AI in the “Health AI” space. Former FTC Commissioner Terrell McSweeny, AI Initiative…
AI Standards Update: NIST Solicits Comments on the Four Principles of Explainable Artificial Intelligence and Certain Other Developments
The National Institute of Standards and Technology (“NIST”) is seeking comments on the first draft of the Four Principles of Explainable Artificial Intelligence (NISTIR 8312), a white paper that seeks to define the principles that capture the fundamental properties…
FDA Issues Final Guidance on Multiple Function Digital Health Software and Other Devices
On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software.
The concept of “multiple function”…
UK ICO publishes guidance on Artificial Intelligence
On July 30, 2020, the UK Information Commissioner’s Office (“ICO”) published its final guidance on Artificial Intelligence (the “Guidance”). The Guidance sets out a framework for auditing AI systems for compliance with data protection obligations under the GDPR and the…
California Legislature Advances Privacy Legislation
Our colleagues at the Inside Privacy blog have summarized a proposed bill in California (the Genetic Information Privacy Act) that would impose certain privacy obligations on direct-to-consumer genetic testing companies that go beyond the California Consumer Privacy Act. This summary…
The “Agile” Path to Market: An Alternative Approach to Food Industry R&D
Software development can teach us a lot about streamlining the research and development (R&D) process in other industries. “Agile development”, or the process of dividing up an R&D project into smaller, more iterative segments instead of planning the entire project…
Germany Prepares New Law for Patient Data Protection and Increased Digitalisation in Healthcare and for “Data Donations” for Research Purposes
On 3 July 2020, the German parliament passed a draft bill (German language) for patient data protection and for more digitalisation in the German healthcare system (Patientendaten-Schutz-Gesetz). The draft bill is currently in the legislative procedure and is…