News & Analysis as of

Medical Devices › Patient Privacy Rights › Health Insurance Portability and Accountability Act (HIPAA)

Verrill

Legal Readiness for AI in Healthcare: A Provider’s Quick Guide

Verrill on

Artificial Intelligence (AI) continues to revolutionize industries and is poised to bring transformative change in healthcare delivery, drug discovery, diagnostics, and data analysis and communication. This technology is...more

Polsinelli

CISA and FDA Sound Alarm on Backdoor Cybersecurity Threat with Patient Monitoring Devices

Polsinelli on

Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...more

Stinson LLP

Health App Vendors Be Warned: You Could Be Subject to FTC's Health Breach Notification Rule

Stinson LLP on

The surge in new health apps and connected devices, which only increased during the pandemic, continues to raise many legal and ethical questions. As a result, lawmakers have been scrambling to define the obligations...more

BakerHostetler

Life Sciences: Connected Medical Devices in the Cloud During COVID-19

BakerHostetler on

The Pandemic has fast-tracked the use of telehealth services. Hussein Akhavannik discusses how medical device companies are looking to add to or expand remote monitoring capabilities. However, some capabilities raise legal...more

Wilson Sonsini Goodrich & Rosati

Digital Health Report: Fall 2019

Wilson Sonsini Goodrich & Rosati on

Beware of “Most Favored Nations” Clauses in Commercial Contracts - Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure...more

K&L Gates LLP

K&L Gates Triage: Artificial Intelligence in Health Care

K&L Gates LLP on

Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more

Knobbe Martens

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

Knobbe Martens on

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more

King & Spalding

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

Arnall Golden Gregory LLP

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

Arnall Golden Gregory LLP on

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

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