Category

Health Privacy

28 September 2021

Federal Trade Commission Hosts Panels Related to Consumer Privacy and Data Security at PrivacyCon

This summer, the Federal Trade Commission (“FTC”) hosted its sixth annual PrivacyCon, an event focused on the latest research and trends related to consumer privacy and data security. This years’ event was divided into six panels: Algorithms; Privacy Considerations and Understandings; Adtech; Internet of Things; Privacy-Children and Teens; and, … Read More

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22 September 2021

Digital Health in the UK: MHRA Bold New (Regulatory) World?

In his statement to the House of Lords on September 16, Lord Frost announced that “we will use the provisions of the Medicines and Medical Devices Act 2021 to overhaul our clinical trial frameworks, based on outdated EU legislation, giving a major boost to the UK’s world-class R&D sector and … Read More

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09 June 2021

NHS’ Plans to Share Patient Records with Third Parties

NHS Digital (the national custodian for health and care data in England) in May 2021, announced a new data sharing initiative called the General Practice Data for Planning and Research (GPDPR) service. The launch of the GPDPR could result in the historical medical records of up to 55 million patients … Read More

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03 May 2021

Part II – Digital Health Passports in Europe: Amended Proposal for a Digital Green Certificate and Eligible Testing Methods

In March 2021, the European Commission released a proposal for the creation of a “Digital Green Certificate,” which will allow EU citizens to travel easier throughout the EU during the COVID-19 pandemic. Last week, the EU Member States agreed on some proposed changes to the proposal, including strengthening of the … Read More

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07 April 2021

Part I – Digital Health Passports in Europe: Facilitating a Return to the “New Normal” or an Intrusion of Privacy?

With the roll-out of the COVID-19 vaccine and the start of easing of social distancing measures, the latest initiative being considered at a national as well as an international level is the introduction of so-called “digital health passports” or “immunity passports,” i.e., a tool to record and share the immune … Read More

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09 March 2021

European Commission Releases Assessment of the EU Member States’ Rules on Health Data in Light of GDPR

On February 12, 2021, the European Commission (Commission) published an “Assessment of the EU Member States’ rules on health data in the light of GDPR” (the Assessment). The Assessment concludes, amongst other things, that there are variations in the implementation of the EU General Data Protection Regulation … Read More

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04 March 2021

East Coast Meets West Coast: Enter the Virginia Consumer Data Protection Act

For over two and a half years, California has enjoyed the spotlight of having the most comprehensive data privacy law in the United States. On March 2, 2021, Virginia forced California to share the honors, when Democratic Gov. Ralph Northam signed into law the Virginia Consumer Data Protection Act (VCDPA).… Read More

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18 February 2021

European Medicines Agency Issues Updated Good Clinical Practice Q&A

On February 17, 2021 the European Medicines Agency (EMA) published an updated version of its good clinical practice questions and answers (GCP Q&A).  The updated section relates to access to patient medical records by GCP inspectors from European Economic Area (EEA) Member States.  It … Read More

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21 January 2021

A Digital Europe – Digital Health and other Recent EU Data Initiatives

Taking a step into the digital age, the European Commission announced that the 2020s shall become the EU’s Digital Decade.  The EU’s digitalization, including in the area of health, is one of the Commission’s key priorities and covers a wide range of actions and related initiatives.

Building on prior initiatives, … Read More

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15 December 2020

HHS Issues Proposed Rule Modernizing HIPAA Privacy Rule

On December 10, 2020, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule (the Proposed Rule) that would make a number of key changes to the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 and the Health … Read More

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