Published Works

USA: Staying secure - FDA's evolving approach to medical device cybersecurity DataGuidance

February 2019

As the introduction of new medical devices continues to become a major part of the US health care sector, the mitigation of cybersecurity risks to such devices is an area of increasing...

Hogan Lovells Publications

Regulatory Insights for Life Sciences and Health Care Investments: Data Privacy and Cybersecurity

17 December 2018

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars.

Hogan Lovells Publications

Regulatory Insights for Life Sciences and Health Care Investments: Digital Health

13 December 2018

Hogan Lovells Publications

Proposed changes to FDA guidance for the content of premarket submissions for management of cybersecurity in medical devices: What you should know Medical Device Alert

19 October 2018

October is National Cybersecurity Awareness Month and the Food and Drug Administration (FDA or the agency) has been busy.

Hogan Lovells Publications

Post-market medical devices, cybersecurity, and the U.S. FDA’s growing concerns

17 January 2018

From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections...

Publications

How the U.S. healthcare sector can prepare for and harden its systems against cyberattack

07 August 2017

“The number one issue on the minds of many CEOs and boards is cyberattacks and data breaches,” said Hogan Lovells partner Marcy Wilder. In this hoganlovells.com interview,...