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Pro Te: Solutio - Vol.9 No.3 – Fall 2016

by Butler Snow LLP on

The Fall 2016 issue of Pro Te is about all things regulatory, including a peek at the newly developing issue of crowdfunding for medical devices. In EMA Guidance on Clinical Data Publication, we discuss recent guidance...more

Outsourcing of Services in the Medical Device Industry

by Knobbe Martens on

As the medical device market continues to grow, the medical device industry has strived to reduce costs through outsourcing. An industry report has found that the global medical device outsourcing market was valued at $33.2...more

Insider Trading Around Private Placements: Was Tom Price’s Investment Down Under Above Board?

On February 10, the Senate confirmed Representative Tom Price (R-GA) as Secretary of Health and Human Services, where he will oversee the U.S. Food and Drug Administration (FDA). His nomination has not been without...more

Tokyo Dispute Resolution & Crisis Management Newsletter – February 2017

by King & Spalding on

Product Pricing and Antitrust Law in the United States - A recent US court action by a Japanese company in respect of a competitor’s volume discounts - Introduction - The current position in the US on the rules...more

The GDPR – Possible Impact on the Life Sciences and Healthcare Sectors

by Ropes & Gray LLP on

Regulation (EU) 2016/679 of the European Parliament and the Council of 27 April 2016, (the “GDPR”) came into force in May 2016 and introduced a number of changes to European data protection law. Such changes will impact upon...more

France imposes an extra notification obligation on Class III and implantable medical devices manufacturers

by Hogan Lovells on

On 13 December 2016, the French Decree 2016-1716[1] implementing the French Law 2016-41 modernising the French healthcare system[2] (“French Law 2016-41”) was adopted. This Decree provides important information concerning the...more

EMA pilot project on tailored scientific advice to support new biosimilars

by Hogan Lovells on

In February 2017, the European Medicines Agency (“EMA”) will launch a pilot project to provide tailored scientific advice for the development of new biosimilars, i.e. biological medicinal products that are similar to a...more

Happy Data Privacy Day! A Few Tips from the MVA Privacy and Data Security Group

by Moore & Van Allen PLLC on

Saturday January 28, 2017 is Data Privacy Day. The Moore & Van Allen Privacy and Data Security group took a break from the pre-holiday revelries to put together some thoughts and tips for DataPoints. So hoist a glass and...more

Monthly TCPA Digest - January 2017

by Mintz Levin on

We are pleased to present the latest edition of our Monthly TCPA Digest, providing insights and news related to the Telephone Consumer Protection Act (TCPA). This month’s issue features updates on the latest regulatory...more

Risk in Compliance Week: Part I – Forecasting

by Thomas Fox on

This week I will feature a series on risk in compliance where I will be joined by Ben Locwin, Director of Global R&D at BioGen and an operational strategist in pharma and healthcare, to explore risk forecast, risk assessment...more

3D Printing Quarterly Report - Q4 2016

by Benesch on

Developments in 3D Printing: A Sector by Sector Overview - This report explores recent developments across a number of sectors as it relates to 3D printing and its impact on each sector. We’ve limited our scan to the...more

AGG Food and Drug Newsletter - January 2017

by Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

"OFAC Eases Restrictions on the Export of Medical Devices to Iran"

On December 22, 2016, the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) announced amendments to the general license (GL) that authorizes the export or re-export of certain medical devices to Iran....more

Peerless, This is Not: Sixth Circuit Finds No Latent Ambiguity in Consent to Settle Requirement in Excess Policy

by Carlton Fields on

Disputes between policyholders and excess insurers often involve events that occurred before the underlying defense costs or indemnity payments reached the excess layer. In Stryker Corp. v. Nat’l Union Fire Ins. Co. of...more

Happy New Year: OFAC Expands Exports of Medical Devices to Iran

by Bass, Berry & Sims PLC on

Effective December 23, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) amended the Iranian Transactions and Sanctions Regulations (ITSR) to expand the scope of medical devices that can be exported to...more

Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics

by Tarter Krinsky & Drogin LLP on

Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more

21st Century Cures: Examining Medical Device Provisions

by McDermott Will & Emery on

The 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment and facilitating innovation review and...more

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

Highlights from McDermott’s 2016 Pharmaceutical/Medtech Dealmaking Symposium

by McDermott Will & Emery on

On October 25, 2016, McDermott Will & Emery held its fifth annual Pharmaceutical/Medtech Dealmaking Symposium in Cambridge, Massachusetts. The day consisted of a series of thought-provoking panels with leading dealmakers in...more

Ninth Circuit Smells a Rat and Reinstates Claim That Pharmaceutical Company Failed to Disclose Cancers in Animal Testing

The Ninth Circuit recently revived a securities class action against Arena Pharmaceuticals, issuing a decision with important guidance to pharmaceutical companies speaking publicly about future prospects for FDA approval of...more

FDA Launches Form for Reporting Allegations of Misconduct by Device Manufacturers

by King & Spalding on

Program Has Broad Reach - On October 21, 2016, the Food and Drug Administration launched a webpage that contains an Allegations of Regulatory Misconduct Form to enable whistleblowers, competitors, and others to report...more

"OFAC and BIS Implement Additional Amendments in Support of Cuba Policy Shift"

On October 14, 2016, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) and the Department of Commerce’s Bureau of Industry and Security (BIS) announced further amendments to ease U.S. sanctions and...more

Recent CyberSecurity Incidents Emphasize Importance of Cyberinsurance

by Akerman LLP - Health Law Rx on

As the threat of cyberattacks continues to pose daily threats to businesses large and small, more companies have turned to cyber insurance products to shore up protection against these disruptive threats. A spate of recent...more

OCR Explains How Information Blocking Violates HIPAA

by McDermott Will & Emery on

The US Department of Health and Human Services Office for Civil Rights recently posted guidance clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a...more

HHS Publishes New Guidance on HIPAA and Cloud Computing

by Stinson Leonard Street on

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has issued a new guidance regarding HIPAA compliance and the use of cloud computing solutions. The guidance is intended to assist covered entities...more

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