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

On December 23, 2020, the European Commission (the “Commission”) published its inception impact assessment (“Inception Impact Assessment”) of policy options for establishing a European Health Data Space (“EHDS”).  The Inception Impact Assessment is open for consultation until February 3, 2021, encouraging “citizens and stakeholders” to “provide views on the Commission’s understanding of the current situation, problem and possible solutions”.

Continue Reading European Commission Conducts Open Consultation on the European Health Data Space Initiative

On 18 January 2021, the UK Parliamentary Office of Science and Technology (“POST”)* published its AI and Healthcare Research Briefing about the use of artificial intelligence (“AI”) in the UK healthcare system (the “Briefing”).  The Briefing considers the potential impacts of AI on the cost and quality of healthcare, and the challenges posed by the wider adoption of AI, including safety, privacy and health inequalities.

The Briefing summarises the different possible applications of AI in healthcare settings, which raises unique considerations for healthcare providers.  It notes that AI, developed through machine learning algorithms, is not yet widely used within the NHS, but some AI products are at various stages of trial and evaluation.  The areas of healthcare identified by the Briefing as having the potential for AI to be incorporated include (among others): interpretation of medical imaging, planning patients’ treatment, and patient-facing applications such as voice assistants, smartphone apps and wearable devices.

Continue Reading AI Update: UK Parliament Research Briefing on AI in the UK Healthcare System

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

On 17 December 2020, the Council of Europe’s* Ad hoc Committee on Artificial Intelligence (CAHAI) published a Feasibility Study (the “Study”) on Artificial Intelligence (AI) legal standards. The Study examines the feasibility and potential elements of a legal framework for the development and deployment of AI, based on the Council of Europe’s human rights standards. Its main conclusion is that current regulations do not suffice in creating the necessary legal certainty, trust, and level playing field needed to guide the development of AI. Accordingly, it proposes the development of a new legal framework for AI consisting of both binding and non-binding Council of Europe instruments.

The Study recognizes the major opportunities of AI systems to promote societal development and human rights. Alongside these opportunities, it also identifies the risks that AI could endanger rights protected by the European Convention on Human Rights (ECHR), as well as democracy and the rule of law. Examples of the risks to human rights cited in the Study include AI systems that undermine the right to equality and non-discrimination by perpetuating biases and stereotypes (e.g., in employment), and AI-driven surveillance and tracking applications that jeopardise individuals’ right to freedom of assembly and expression.

Continue Reading The Council of Europe Publishes Feasibility Study on Developing a Legal Instrument for Ethical AI

On January 6, 2021 the UK’s Department of Health and Social Care (“DHSC”)  published “A Guide to Good Practice for Digital and Data-Driven Health Technologies” (the “Guidance”).  The Guidance updates the DHSC’s “Code of Conduct for Data-Driven Health and Care Technologies” (the “Code”) (for further information on the Code see our earlier blog, here).

As with the Code, the Guidance is a valuable resource to help parties understand what the National Health Service (“NHS”) looks for when acquiring digital and data-driven technologies for use in health and care.

Continue Reading UK’s Department of Health and Social Care Publishes Updated Guidance on Good Practice for Digital and Data-Driven Health Technologies

On December  10, 2020, the Office for Civil Rights (“OCR”) of the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule to modify the Standards for the Privacy of Individually Identifiable Health Information (the “Privacy Rule”) promulgated under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”).  According to HHS’s announcement, the proposed rule would amend the Privacy Rule to “support individuals’ engagement in their care, remove barriers to coordinated care, and reduce regulatory burdens on the health care industry.”  Public comments on the proposed rule are currently being accepted through February 12, 2021.

The proposed rule is part of HHS’s Regulatory Sprint to Coordinated Care, initiated pursuant to Secretary Alex Azar’s value-based transformation agenda, which seeks to “promote value-based care by examining federal regulations that impede efforts among health care providers and health plans to better coordinate care for patients.”  Throughout the Privacy Rule, HHS sought to protect health information while also permitting information sharing for certain beneficial purposes.  However, stakeholders have questioned whether the Privacy Rule strikes the appropriate balance in certain situations.

Proposed modifications to the HIPAA Privacy Rule include strengthening individuals’ right to access their protected health information (“PHI”), including electronic PHI; facilitating greater family involvement in care for individuals dealing with health crises or emergencies; and allowing providers more flexibility to disclose PHI when harm to a patient is “serious and reasonably foreseeable,” such as during the opioid crisis or COVID-19 public health emergency.  Importantly, multiple provisions of the proposed rule, discussed in greater detail below, address electronic health records (“EHRs”) and personal health applications.

Continue Reading HHS Announces Proposed Changes to HIPAA’s Privacy Rule

On 25 November 2020, the European Commission published a proposal for a Regulation on European Data Governance (“Data Governance Act”).  The proposed Act aims to facilitate data sharing across the EU and between sectors, and is one of the deliverables included in the European Strategy for Data, adopted in February 2020.  (See our previous blog here for a summary of the Commission’s European Strategy for Data.)  The press release accompanying the proposed Act states that more specific proposals on European data spaces are expected to follow in 2021, and will be complemented by a Data Act to foster business-to-business and business-to-government data sharing.

The proposed Data Governance Act sets out rules relating to the following:

  • Conditions for reuse of public sector data that is subject to existing protections, such as commercial confidentiality, intellectual property, or data protection;
  • Obligations on “providers of data sharing services,” defined as entities that provide various types of data intermediary services;
  • Introduction of the concept of “data altruism” and the possibility for organisations to register as a “Data Altruism Organisation recognised in the Union”; and
  • Establishment of a “European Data Innovation Board,” a new formal expert group chaired by the Commission.

Continue Reading The European Commission publishes a proposal for a Regulation on European Data Governance (the Data Governance Act)

On 11 November 2020, the European Data Protection Board (“EDPB”) issued two draft recommendations relating to the rules on how organizations may lawfully transfer personal data from the EU to countries outside the EU (“third countries”).  These draft recommendations, which are non-final and open for public consultation until 30 November 2020, follow the EU Court of Justice (“CJEU”) decision in Case C-311/18 (“Schrems II”).  (For a more in-depth summary of the CJEU decision, please see our blog post here and our audiocast here. The EDPB also published on 24 July 2020 FAQs on the Schrems II decision here).

The two recommendations adopted by the EDPB are:

Continue Reading EDPB adopts recommendations on international data transfers following Schrems II decision

On September 30, 2020, the Cybersecurity and Infrastructure Security Agency (“CISA”) and the Multi-State Information Sharing and Analysis Center (“MS-ISAC”) released a joint guide synthesizing best practices to prevent and respond to ransomware.  This guide was published the day before OFAC and FinCEN released their coordinated guidance on ransomware attacks that we previously summarized here.

Ransomware is malware that encrypts data on a victim’s device, thus rendering the data inaccessible, until a ransom is paid in exchange for decryption.  Both the nature and scope of ransomware incidents have become “more destructive and impactful” in recent years.  In particular, tactics of malicious actors include threatening to release stolen data or publicly naming victims as part of the extortion.  Accordingly, the guide encourages organizations to take proactive efforts to manage risks posed by ransomware and recommends a coordinated response to mitigate its impact.

The guide is divided into two parts.  First, the guide focuses on best practices for ransomware prevention, focusing on the common infection vectors—misconfigurations, internet-facing vulnerabilities, phishing, precursor malware infection, third party sources, and managed service providers.  For example, threat actors often gain access to an organization’s network through exposed or insecure remote desktop services.  Employing best practices for use of remote desktop protocol (“RDP”), closing unused RDP ports on firewalls, and tracking RDP login attempts are few of the recommended risk-mitigating exercises.  This part also outlines general best practices for cyber hygiene, including employing multi-factor authentication, implementing the principle of least privilege, and retaining and securing logs.  These actions not only mitigate the risk of ransomware but other cybersecurity threats as well.

The second part of the guide focuses on responding to ransomware in three stages.

  • Detection and Analysis. Immediate isolation and triage of impacted systems are the priorities.  Because threat actors may monitor the organization’s activity or communications following intrusion, the guide recommends using means to avoid the threat actor knowing it has been detected—such as communicating by phone and not email.  The guide recommends not paying the ransom, because such payments will not ensure that data is decrypted or that the system is no longer compromised.
  • Containment and Eradication. Depending on the ransomware variant, consulting with federal law enforcement or other trusted entities may be worthwhile, as security researchers may have already broken the encryption algorithms or have published information on ransomware binaries and associated registry values.  Otherwise, a methodical approach to identifying, containing, and removing any compromise to the system will be critical.
  • Recovery and Post-Incident Activity. Documenting the lessons learned from the ransomware will help inform future policies and procedures. Sharing this information can also benefit others in the community.

For organizations seeking further information on ransomware, the guide offers a list of resources from CISA and MS-ISAC.  These include regional CISA Cybersecurity Advisors, who advise on best practices to manage cyber risk.

Lawyers who support organizations that face ransomware threats should be familiar with these best practices for ransomware prevention and response, and initiate discussions about how their organizations can best prepare for and meet the threats posed by ransomware.  This is increasingly critical at a time when governmental regulators are warning private companies that payments to ransomware actors can implicate legal risks, such as sanctions risk and regulatory obligations under the Bank Secrecy Act.