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Software › Digital Health › Cybersecurity

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Goodwin

Top IP, FDA, and Compliance Issues for Medtech Companies Transitioning to Data-Enabled Product Solutions

Goodwin on

Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data. ​​​​​​​ Companies that once only developed hardware-based solutions for...more

Wiley Rein LLP

Wireless Roundup (March 2022)

Wiley Rein LLP on

Key Wireless Deadlines- NIST Requests Comment on Staging Cybersecurity Risks for Enterprise Risk Management and Governance Oversight: The National Institute of Standards and Technology (NIST) seeks comment on Draft NISTIR...more

King & Spalding

New Standard Maps Medical Device Software Development Standard to Health Software and Health IT Cybersecurity

King & Spalding on

The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a significant impact on...more

Foley & Lardner LLP

FDA Addresses the Role of Digital Health Technology in Clinical Trials

Foley & Lardner LLP on

The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data. DHT can take the form of hardware and...more

McDermott Will & Schulte

To Market, To Market: FDA’s Digital Health Precertification Program

McDermott Will & Schulte on

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

King & Spalding

FDA Tackles Digital Health Software Devices with New Pre-Certification Review Plan

King & Spalding on

On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more

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