Archives: Data Security

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CISA and MS-ISAC Release Joint Guide on Ransomware

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. … Continue Reading

California Legislature Advances Privacy Legislation

Our colleagues at the Inside Privacy blog have summarized a proposed bill in California (the Genetic Information Privacy Act) that would impose certain privacy obligations on direct-to-consumer genetic testing companies that go beyond the California Consumer Privacy Act.  This summary may be of interest to entities that process genetic data in California.… Continue Reading

EHR Interoperability: Public Health Benefits & Privacy Considerations

Public-health researchers, officials and medical professionals rely on data to track outbreaks, advance research, and evaluate prospective treatments. One critical source of patient data comes from electronic health records (EHRs).  EHR data in the U.S. has traditionally been siloed within hospital IT systems, but the federal government and key healthcare stakeholders have recently ramped up … Continue Reading

FTC to Consider Changes to the Health Breach Notification Rule

On May 8, 2020, the Federal Trade Commission (“FTC”) issued a notice soliciting public comment regarding whether changes should be made to its Health Breach Notification Rule (the “Rule”).  The request for comment is part of a periodic review process “to ensure that [FTC rules] are keeping pace with changes in the economy, technology, and … Continue Reading

NHSX Publishes “Buyer’s Checklist” for AI Solutions

NHSX recently published “A Buyer’s Checklist for AI in Health and Care” (Guidance) that sets out 10 key questions which will be of use to parties deploying AI solutions or conducting data driven projects (in a health and care setting or otherwise).  For example, the Guidance highlights: key data-related considerations, such as can the outcome … Continue Reading

Ideation Question #8: What is Novel in the Digital Health Solution and What Will Give the Solution a Competitive Advantage?

This is the eighth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: what is novel in the digital health solution and what will give the solution a competitive advantage?… Continue Reading

Ideation Question #7: Are Healthcare Providers Involved, and What Questions Should Be Considered for Collaborations?

This is the seventh of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process.  Today’s video explores the question: are healthcare providers involved, and what questions should be considered for collaborations?… Continue Reading

Top 10 Questions During Ideation of Digital Health Solutions

Our clients increasingly apply agile product and business development methodologies when they are developing digital health solutions.  “Ideation” is the part of that process and involves the rapid identification and creation of ideas for digital health solutions, which are then prototyped and tested.  Covington has created a Top 10 Questions for Ideation of Digital Health … Continue Reading

UK Government’s Guide to Using AI in the Public Sector

On June 10, 2019, the UK Government’s Digital Service and the Office for Artificial Intelligence released guidance on using artificial intelligence in the public sector (the “Guidance”).  The Guidance aims to provide practical guidance for public sector organizations when they implement artificial intelligence (AI) solutions. The Guidance will be of interest to companies that provide … Continue Reading

NMPA Releases Draft Good Manufacturing Practice Appendix on Standalone Software

On January 3, 2019, the National Medical Products Administration (“NMPA”) published a draft standalone software appendix of medical device good manufacturing practice (“Draft Standalone Software GMP” or “Draft Appendix”) for public comment (available here).  Comments are due on January 30, 2019. China revised its medical device GMP in 2014, which apply to all classes of … Continue Reading

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 technology across the health and care system, from “getting the … Continue Reading

ICO consults on privacy “regulatory sandbox”

Designing data-driven products and services in compliance with privacy requirements can be a challenging process.  Technological innovation enables novel uses of personal data, and companies designing new data-driven products must navigate new, untested, and sometimes unclear requirements of privacy laws, including the General Data Protection Regulation (GDPR).  These challenges are often particularly acute for companies … Continue Reading

Covington Artificial Intelligence Update: House of Lords Select Committee publishes report on the future of AI in the UK

Reflecting evidence from 280 witnesses from the government, academia and industry, and nine months of investigation, the UK House of Lords Select Committee on Artificial Intelligence published its report “AI in the UK: ready, willing and able?” on April 16, 2018 (the Report). The Report considers the future of AI in the UK, from perceived … Continue Reading

CMS Announces MyHealthEData Initiative to Promote Patient Access to Health Data

On March 6, 2018, CMS announced the MyHealthEData initiative, which aims to give patients easier access to and control over their medical records. Announcing the initiative, CMS Administrator Seema Verma laid out a future where individuals will have access to their health data wherever they go and be able to share data with the push … Continue Reading

Open Source Considerations for Digital Health Ventures

Technology companies widely use open source software (“OSS”), which carries with it many potential benefits.  It can reduce the time and cost of development, and, to the extent that the code has been vetted by numerous other developers, may contain fewer bugs.  OSS can also reduce dependency upon third party vendors and associated pricing risks. … Continue Reading

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 puzzle. AI, Data Privacy, and Cybersecurity 1. … Continue Reading
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