News & Analysis as of

Medical Devices Risk Mitigation

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

Womble Bond Dickinson

Automated External Defibrillators: An Untapped Source of Medical Records?

Womble Bond Dickinson on

An estimated 350,000 out-of-hospital cardiac arrest deaths occur each year in the U.S. Approximately 10% of those who experience out-of-hospital cardiac events survive. Use of automated external defibrillators (AED), however,...more

Arnall Golden Gregory LLP

FDA Tries to Keep Up: FDA Publishes Two New Items Related to Artificial Intelligence

FDA has recently published two much-anticipated items related to artificial intelligence (“AI”), one pertaining to medical devices and the other to drug manufacturing. FDA has cleared or approved hundreds of products that...more

American Conference Institute (ACI)

[Event] 18th Annual FCPA & Anti-Corruption for the Life Sciences Industry - May 10th - 11th, New York, NY

Hosted by American Conference Institute, the 18th Annual Conference on the FCPA & Anti-Corruption for the Life Sciences Industry returns for another exciting year with curated programming that shines a global spotlight on...more

Baker Donelson

Mitigating Cyber Vulnerabilities in Medical Devices

Baker Donelson on

Earlier this week, the Federal Bureau of Investigation (FBI) published another notification alerting health care providers of increasing cyber threats to medical devices operating on unpatched or outdated devices. In its...more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Health Care Compliance Association (HCCA)

'Ecosystem' of Connected Devices Heightens Cybersecurity Risk

Report on Medicare Compliance 31 no. 18 (May 16, 2022) - In a version of the future that hopefully never comes, malware is able to remove malignant-looking tumors from CT or MRI scans before they were reviewed by...more

Arnall Golden Gregory LLP

[Webinar] FDA Enforcement in the Product Promotion and Advertising World: (A Little Late 2021) Year in Review and Issues to...

Please join AGG Food & Drug attorneys Alan G. Minsk and Laura S. Dona for a complimentary webinar reviewing past FDA letters issued to pharmaceutical and medical device companies for unlawful promotion in 2021 and where FDA...more

Goodwin

Mitigation of Cybersecurity Risks in Medical Device Software: FDA Discussion & Insights for OEMs, Remanufacturers, and Servicers

Goodwin on

I. OVERVIEW - The U.S. Food & Drug Administration (“FDA”) has increased its focus on mitigating cybersecurity risks in medical device software. On June 24, 2021, the FDA issued two documents that are important not only...more

McGuireWoods LLP

Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future

McGuireWoods LLP on

Episode eight of McGuireWoods’ video series “Healthcare Headlines” is now available. Hosted by McGuireWoods partner Amber McGraw Walsh, a member of the firm’s nationally recognized Healthcare Department, this episode welcomes...more

King & Spalding

EU Sets Global Standard with First Ever Artificial Intelligence Act

King & Spalding on

EU Regulation on Artificial Intelligence - On April 21, 2021 the European Commission published its Proposal for a Regulation on Artificial Intelligence, the first ever legal framework on AI. With its Proposal the European...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Research Compliance Conference - June 14th - 16th, 9:00 am - 5:00 pm CDT

Attend HCCA’s annual Research Compliance Conference to receive the latest insights and guidance on emerging research compliance risks and solutions. This virtual event, held June 14 – 16, will be live and interactive. Learn...more

Hogan Lovells

Looking ahead to 2021: AI – A brave new world?

Hogan Lovells on

In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most recently, AI has been used in the...more

American Conference Institute (ACI)

[Virtual Event] 25th Annual Conference on Drug & Medical Device Litigation - December 8th - 9th, 8:45 am - 5:45 pm EST

Join us as we celebrate the 25th Anniversary of ACI’s Annual Flagship Conference on Drug & Medical Device Litigation! ACI’s Drug and Medical Device Litigation has united the greatest minds of the pharmaceutical and medical...more

Blake, Cassels & Graydon LLP

Blakes Continuity Podcast: Life Sciences: Liability and Immunity During COVID-19

Businesses in the life sciences industry are rightfully concerned about potential negligence claims during COVID-19. Will courts provide immunity or forgiveness? To learn more about how businesses can mitigate the risks,...more

McDermott Will & Emery

FDA Update: COVID-19 Testing, Vaccine Development and Other Impacts

McDermott Will & Emery on

In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more

Shook, Hardy & Bacon L.L.P.

Now That Your Surgical Robot Has Hit the Market, When Will the Lawsuits Start?

Death and taxes are unavoidable. And if you create a popular product, so too are product liability lawsuits. In my practice, companies sometimes ask, “How soon after our surgical robot hits the market will we get sued?”...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - February 2020 #2

Robinson & Cole LLP on

Ransomware Attacks Predicted to Occur Every 11 Seconds in 2021 with a Cost of $20 Billion - Confirming what we are seeing in the field, cybersecurity firm Cybersecurity Ventures has predicted that, globally, businesses in...more

Holland & Knight LLP

Impact of the New Health Industry Cybersecurity Practices: 2019 Outlook

Holland & Knight LLP on

• The U.S. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more

Verrill

Is Cybersecurity on Your 2019 Work Plan?

Verrill on

On December 28, 2018, the U.S. Department of Health and Human Services (“HHS”) closed out the year by releasing long-awaited voluntary cybersecurity guidelines for the health care industry. The four-volume publication,...more

Farrell Fritz, P.C.

Legislation Affecting the Pharmaceutical Industry

Farrell Fritz, P.C. on

During a year in which legislative activity was restrained by a variety of factors, most notably the Senate’s inability to maintain a consistent majority, the New York State Legislature nonetheless still passed 641 bills,...more

Holland & Knight LLP

Congress Continues Push on Medical Device Cybersecurity Mandates - FDA Issues Medical Device Safety Action Plan; DHS Continues to...

Holland & Knight LLP on

Cybersecurity risks to the health and medical device sector continue to be front and center both in Congress and the executive branch, with increasing risks coming from nation states, nonstate actors and other attackers. The...more

King & Spalding

King & Spalding Lawyers Discuss The Regulatory Landscape At Medical Device Cybersecurity Risk Mitigation Conference

King & Spalding on

On July 25 and 26, 2016, industry stakeholders assembled in Arlington, Virginia, to participate in the Medical Device Cybersecurity Risk Mitigation Conference sponsored by Q1 Productions. The conference focused on the...more

Arnall Golden Gregory LLP

U.S. Market Entry for the German Healthcare IT Company

The healthcare market in the United States is massive, with total spending in excess of $3 trillion. Federal government incentives for the adoption of electronic health records has resulted in an increasingly interoperable...more

27 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide