On 15 January 2025, the European Commission published an action plan on the cybersecurity of hospitals and healthcare providers (the “Action Plan”). The Action Plan sets out a series of EU-level actions that are intended to better protect the healthcare sector from cyber threats. The publication of the Action Plan follows a number of high-profile incidents in recent years where healthcare providers across the European Union have been the target of cyber attacks.Continue Reading European Commission Publishes Action Plan on Cybersecurity of Hospitals and Healthcare Providers
German Federal Office for Information Security Publishes Security Requirements for Healthcare Apps
On June 23, 2022, the German Federal Office for Information Security (“Office”) published technical guidelines on security requirements for healthcare apps, including mobile apps, web apps, and background systems. Although the technical guidelines are aimed at healthcare app developers, they contain useful guidance for developers of any app
Continue Reading German Federal Office for Information Security Publishes Security Requirements for Healthcare AppsHITECH Amendment Provides Some Protection For Covered Entities and Business Associates that Adopt Recognized Security Standards
On January 5, 2021, an amendment to the Health Information Technology for Economic and Clinical Health (“HITECH”) Act was signed into law. The amendment requires the U.S. Department of Health and Human Services (“HHS”) to “consider certain recognized security practices of covered entities and business associates when making certain determinations” regarding fines, audit results, or other remedies for resolving potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). For organizations subject to HIPAA, the amendment provides substantial incentives to establish or improve their cybersecurity programs. While it does not establish a complete safe harbor from HIPAA enforcement, the amendment does offer organizations a chance to mitigate financial penalties and other negative regulatory actions that may result from a data breach.
Continue Reading HITECH Amendment Provides Some Protection For Covered Entities and Business Associates that Adopt Recognized Security Standards
Proposed New EU Cyber Rules Introduce More Onerous Requirements and Extend to More Sectors
In addition to releasing the new EU Cybersecurity Strategy before the holidays (see our post here), the Commission published a revised Directive on measures for high common level of cybersecurity across the Union (“NIS2”) and a Directive on the resilience of critical entities (“Critical Entities Resilience Directive”). In this blog post, we summarize key points relating to NIS2, including more onerous security and incident reporting requirements; extending requirements to companies in the food, pharma, medical device, and chemical sectors, among others; and increased powers for regulators, including the ability to impose multi-million Euro fines.
The Commission is seeking feedback on NIS2 and the Critical Entities Resilience Directive, and recently extended its original deadline of early February to March 11, 2021 (responses can be submitted here and here).Continue Reading Proposed New EU Cyber Rules Introduce More Onerous Requirements and Extend to More Sectors
AI, IoT, and CAV Legislative Update: EU Spotlight (Third Quarter 2020)
In this edition of our regular roundup on legislative initiatives related to artificial intelligence (AI), cybersecurity, the Internet of Things (IoT), and connected and autonomous vehicles (CAVs), we focus on key developments in the European Union (EU).
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Commission relaunch of eHealth Stakeholder Group
On 13 August 2019, the European Commission opened a call for expression of interest to relaunch the eHealth Stakeholder Group with a view to supporting the “digital transformation of healthcare in the EU”. The eHealth Stakeholder Group was first launched in 2012 and in its first iteration (between 2012 and
Continue Reading Commission relaunch of eHealth Stakeholder Group
French medicines regulator produces first in Europe medical devices cybersecurity guidelines
France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first
Continue Reading French medicines regulator produces first in Europe medical devices cybersecurity guidelines
UK Government publishes new policy paper outlining vision for digitizing health care and becoming a global leader in healthtech
On 17 October, the UK Government’s Department of Health and Social Care (DHSC) published a policy paper entitled “The future of healthcare: our vision for digital, data and technology in health and care” (the Policy Paper). The Policy Paper outlines the DHSC’s vision to use
Continue Reading UK Government publishes new policy paper outlining vision for digitizing health care and becoming a global leader in healthtech
Latest NIST Draft Report a Call to Action for Federal Agencies and Private Companies
Inflection Point for IoT
In a relatively short amount of time, the adoption of the Internet of Things (IoT) and its applications— from smart cars to the myriad of interconnected sensors in the General Service Administration building reminiscent of HAL 9000 from 2001: A Space Odyssey— has rapidly proliferated, providing
Continue Reading Latest NIST Draft Report a Call to Action for Federal Agencies and Private Companies
Digital Health Checkup (Part Three): Key Questions About AI, Data Privacy, and Cybersecurity
In the third installment of our series, Covington’s global cross-practice Digital Health team considers some additional key questions about Artificial Intelligence (AI), data privacy, and cybersecurity that companies across the life sciences and technology sectors should be asking to address the regulatory and commercial pieces of the complex digital health
Continue Reading Digital Health Checkup (Part Three): Key Questions About AI, Data Privacy, and Cybersecurity