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.
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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
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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
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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
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UK Government Considering New Patient Data Security and Research Consent Standards, Sanctions
The UK Government has opened a consultation, running until September 7, 2016, regarding how UK National Health Service (NHS) patient data should be safeguarded, and how it could be used for purposes other than direct care (e.g. scientific research).
The consultation comes after two parallel-track reviews of information governance and data security arrangements in the NHS found a number of shortcomings, described below. The Care Quality Commission (CQC) and the National Data Guardian (NDG, led by Dame Fiona Caldicott) made a range of recommendations, including new security standards, stronger inspection and enforcement around security lapses and re-identification of anonymized patient data, and an eight-point process around assuming and respecting patient consent decisions.
Following the public consultation, the new security standards could eventually be required and audited by government inspectors from the CQC, and imposed under revised standard NHS England contract terms. CQC inspectors could potentially act on tip-offs from NHS Digital (formerly known as the NHS Health and Social Care Information Centre, ‘HSCIC’). Those tip-offs could be based on low scores obtained by organizations in their annual NHS Information Governance Toolkit (IGT) self-assessments. The IGT, which the reviewers said should be redesigned, applies both to NHS bodies and their commercial vendors.
The new consent model, meanwhile, could provide more streamlined, system-wide consents for use of patient data for purposes including quality assurance and research.
The CQC and the NDG’s findings and twenty-four recommendations were jointly presented in a covering letter to the UK government, available here, and fuller reports, available here and here (CQC and NDG, respectively). This post provides a brief summary of their main findings and recommendations. For the consultation questions themselves, see here.
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