Tag Archives: Artificial Intelligence (AI)

FDA Outlines Updated Approach to Regulating Digital Health Technologies

On December 8, FDA addressed the agency’s evolving approach to digital health by issuing two new draft guidance documents: “Clinical and Patient Decision Support Software” (the “CDS Draft Guidance”) and “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act” (the “Software Policies Draft Guidance”). These draft guidances announce the … Continue Reading

Digital Health Checkup (Part Three): Key Questions About AI, Data Privacy, and Cybersecurity

In the third installment of our series, Covington’s global cross-practice Digital Health team considers some additional key questions about Artificial Intelligence (AI), data privacy, and cybersecurity that companies across the life sciences and technology sectors should be asking to address the regulatory and commercial pieces of the complex digital health puzzle. AI, Data Privacy, and Cybersecurity 1. … Continue Reading

European Cloud in Health Advisory Council Calls For Review of eHealth Rules and Ethics of Medical Data Re-Use

On May 11, 2017, the European Cloud in Health Advisory Council (ECHAC) – a group of healthcare organizations, technology companies and patient representatives  –  launched its second whitepaper focused on use of data to improve health outcomes and delivery of care. ECHAC launched the whitepaper at an eHealth Week 2017 session attended by ECHAC participants and … Continue Reading