Tag Archives: Health data

Patient Access to Electronic Health Data at the Forefront of Two HHS Proposed Rules

On March 4, 2019, the Department of Health and Human Services (HHS) published two proposed rules to improve patient access to personal health data. The two rules, issued by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), are intended to increase interoperability … Continue Reading

EMA-HMA joint taskforce publish report outlining recommendations for using ‘big data’ for medicines regulation

On 15 February 2019, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) published their Joint Big Data Taskforce’s summary report (available here) setting out recommendations for understanding the acceptability of evidence derived from ‘big data’ in support of the evaluation and supervision of medicines by regulators. The Taskforce has sought to clarify … Continue Reading

EESC supports the digital transformation of EU healthcare sector, emphasising data access and ownership as ‘crucial’ to the process

On 6 December 2018, the European Economic and Social Committee (EESC) published an opinion (“Opinion”) addressing the European Commission’s recent Communication on the digital transformation of health and care in the Digital Single Market (issued 25 April 2018). The EESC is an advisory body of the European Union (“EU”) comprising representatives of workers’ and employers’ … Continue Reading

EMA publishes “A Common Data Model for Europe? – Why? Which? How?” Workshop Report

On 8 October, the European Medicines Agency (EMA) published a report (available here) setting out the progress it has made towards applying a common data model (CDM) in Europe. The EMA defines a CDM as “a mechanism by which raw data are standardized to a common structure, format and terminology independently from any particular study … Continue Reading

Summary of the CPS Paper on the Integration of Technology in the UK’s National Health Service

On 1 May, 2018 the Centre for Policy Studies (the “CPS”) published its latest paper on the UK’s National Health Service (the “NHS”) entitled “Powerful Patients, Paperless Systems: How New Technology Can Renew The NHS” (the “Paper”). The Paper advocates a “digital first NHS” that adopts a paperless system and enables patients to take full … Continue Reading

Summary of the European Commission’s eHealth Strategy

On the April 25, 2018 the European Commission (the “Commission”) adopted a plan of action to enable the digital transformation of health and care in the Digital Single Market (the “Communication”), intended to put EU citizens at the centre of the healthcare system.  This is to be achieved in three ways: 1. Citizens’ secure access … Continue Reading

Three Questions You Need to Ask When Negotiating Digital Health Deals

According to a distinguished panel of lawyers from MSD and Covington & Burling, companies involved in Digital Health deals need to ask themselves the following questions: What data is required to develop and deliver the Digital Health solution, and does your company have sufficient expertise in-house to analyze the data? What happens if your technology … Continue Reading
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