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Cybersecurity › Regulatory Oversight › Medical Devices

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 -
Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 119

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 115

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...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

OIG Issues Report Regarding Medicare Oversight of Cybersecurity for Networked Medical Devices in Hospitals

King & Spalding on

On June 21, 2021, OIG released a report titled “Medicare Lacks Consistent Oversight of Cybersecurity for Networked Medical Devices in Hospitals” (OEI-01-20-00220) (the OIG Report). OIG determined that CMS’s accreditation...more

Akin Gump Strauss Hauer & Feld LLP

FDA Releases Action Plan for Artificial Intelligence/Machine Learning-Enabled Software as a Medical Device

Akin Gump Strauss Hauer & Feld LLP on

Key Points - FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices. - FDA plans to pilot Real-World Performance...more

McDermott Will & Emery

[Event] Life Sciences Bootcamp For In-house Counsel - March 19th, Cambridge, MA

McDermott Will & Emery on

The life sciences industry faces a wide range of legal, regulatory and business challenges, along with constantly evolving trends that impact leadership priorities. McDermott’s cross-functional team of life sciences...more

Hogan Lovells

Harmonizing cybersecurity for medical devices: International collaboration moves forward

Hogan Lovells on

On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical Device Cybersecurity" (IMDRF...more

McDermott Will & Emery

To Market, To Market: FDA’s Digital Health Precertification Program

McDermott Will & Emery on

In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more

Hogan Lovells

Proposed changes to FDA guidance for the content of premarket submissions for management of cybersecurity in medical devices: What...

Hogan Lovells on

On October 18, 2018, FDA issued a long-awaited draft revision to its existing guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"(premarket cybersecurity guidance). This coincided...more

Hogan Lovells

Clinical trials: Digital technology for recruitment, consent, and data capture

Hogan Lovells on

The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is...more

Hogan Lovells

Best practices for managing cybersecurity risks related to IoT-connected medical devices

Hogan Lovells on

Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more

Hogan Lovells

Working Together: FDA Releases Final Guidance on Interoperability

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On September 6, 2017, the Food and Drug Administration (FDA or the Agency) released its final guidance document, Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices (Final...more

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