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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +
Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now.   less -
Ropes & Gray LLP

Glow Up or Sell Out? Opportunities and Risks in the Consumer Health and Beauty Sector

Ropes & Gray LLP on

The global M&A market is forever evolving, and nowhere is this truer than in beauty, which has recently seen a notable surge in growth and popularity. McKinsey forecasts global beauty sales to grow six percent annually until...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

BakerHostetler

FTC Continues Focus on Disclosure of Health Information to Third-Party Technologies

BakerHostetler on

A recently announced settlement with online alcohol addiction treatment service Monument Inc. demonstrates the Federal Trade Commission’s (FTC) continued focus on the use and disclosure of health data. The proposed settlement...more

Health Care Compliance Association (HCCA)

Privacy Briefs: May 2024

Health Care Compliance Association (HCCA) on

Kaiser Permanente is notifying 13.4 million current and former members that their personal information may have been compromised when it was transmitted to tech giants Google, Microsoft Bing and X (formerly Twitter) when...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Skadden, Arps, Slate, Meagher & Flom LLP on

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Health Care Compliance Association (HCCA) on

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...more

J.S. Held

Inside the Healthcare Industry: Understanding Emerging Data Privacy & Security Risks and Regulations

J.S. Held on

According to the Theft Resource Center and its 2022 data breach reports, data privacy and security threats are impacting all aspects of the healthcare industry – from providers to payers to medical device companies to...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

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 23, Number 2. Privacy Briefs: February 2023

Health Care Compliance Association (HCCA) on

Report on Patient Privacy Volume 23, no 2 (February 2023) DCH Health Systems, based in Tuscaloosa, Ala., said it fired an employee in December after a routine privacy audit revealed evidence that the worker had accessed some...more

Hogan Lovells

FTC emphasizes expectations around the health breach notification rule

Hogan Lovells on

The Federal Trade Commission (FTC) recently has signaled its intent to inject new life into a longstanding but rarely triggered rule governing health breach notifications for non-HIPAA-covered health records. Specifically,...more

Morgan Lewis

Digital Health Trends to Watch in 2022

Morgan Lewis on

In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...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

Smart & Biggar

Health Canada paving the way for more AI/ML medical devices

Smart & Biggar on

Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as...more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2021

Jones Day on

NOTE FROM THE EDITORS - The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more

Mayer Brown Free Writings + Perspectives

Global Corporate VC Trends in 2020

Mayer Brown Free Writings + Perspectives on

CB Insights summarized 2020 corporate venture capital (“CVC”) financing trends in 2020 in its recent report. Globally, CVC-led deals raised over $73.1 billion in 2020 in 3,359 transactions....more

Lowenstein Sandler LLP

A Look Ahead: US FDA And Medical Device Regulations In 2021

Lowenstein Sandler LLP on

The pandemic year of 2020 presented FDA with many enormous challenges, including how to use emergency authorizations to approve diagnostic tests, personal protective equipment, and therapies, how to conduct remote...more

Jones Day

Vital Signs Digital Health Law Update | Winter 2021

Jones Day on

Note from the Editors - Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more

McDermott Will & Emery

Policy Outlook: How The 2020 Election Outcomes Will Impact Your Business - Health Policy

McDermott Will & Emery on

In this session, health law policy authorities discussed changes likely in 2021 in a Biden Administration and how these changes will impact business objectives and strategies for health industry stakeholders...more

McDermott Will & Emery

[Webinar] Policy Outlook: How The 2020 Election Outcomes Will Impact Your Business - November 5th, 12:00 pm - 2:15 pm EST

McDermott Will & Emery on

Are you prepared for the critical impacts of the US election outcome to you and your business in 2021 and beyond? Join McDermott’s lawyers and our policy and lobbying team for perspective on the effects of administration...more

Womble Bond Dickinson

Wellness Wearables and Big Data

Womble Bond Dickinson on

Nearly half of Americans have tried wellness wearables or another digital health product. In a global pandemic, can we use the information tracked by wellness wearables to help prevent further spread and infection?...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 20, Number 1. Privacy Briefs: January 2020

Health Care Compliance Association (HCCA) on

Report on Patient Privacy 20, no. 1 (January 2020) - ? A cybersecurity breach temporarily halted cancer radiation treatment services at the Cancer Center of Hawaii on Oahu,[1] the center said. The center, which provides...more

Sheppard Mullin Richter & Hampton LLP

FDA Year in Review: A Shifting Regulatory Landscape

Sheppard Mullin Richter & Hampton LLP on

The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning...more

McDermott Will & Emery

2018 Digital Health Year in Review: Focus on Care Coordination and Reimbursement

McDermott Will & Emery on

In 2018, even more than in recent years, federal lawmakers and regulators continued the push toward modernizing the existing legal framework to support and encourage digital health adoption in the context of care coordination...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

Mintz - Health Care Viewpoints

FDA 2018 Year in Review (and a Few Thoughts on 2019)

Mintz - Health Care Viewpoints on

As 2019 quickly approaches, we would like to take a few moments to reflect on the past year of Food and Drug Administration activities and certain big ticket items that made news in 2018. As the Magic 8-Ball would say: “signs...more

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