Tag Archives: Health data

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

HHS Announces Enforcement Discretion Over the Implementation of Interoperability Final Rules Due to COVID-19 Public Health Emergency

On April 21, 2020, the Department of Health and Human Services (“HHS”) announced that, as a response to the COVID-19 public health emergency, it will exercise enforcement discretion to “permit compliance flexibilities” regarding the implementation of the interoperability final rules issued on March 9th, 2020.  This joint announcement was made by the Office of the … Continue Reading

HHS Seeks to Facilitate Certain Uses and Disclosures of Health Data to Public Health and Health Oversight Agencies Amidst COVID-19 Nationwide Public Health Emergency

On April 2, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a Notification of Enforcement Discretion (the “Notification”) regarding the disclosure of protected health information (“PHI”) to public health authorities and use of PHI to perform analytics for such authorities.  Designed to “facilitate uses and disclosures for public health and health oversight … Continue Reading

Covington Publishes Coronavirus/COVID-19 Checklist for Technology Solutions

To assist companies that are developing technology solutions to help predict, mitigate or contain the spread of COVID-19, our cross-practice digital health team has put together a checklist of considerations to keep in mind (available here). For additional guidance, please visit our COVID-19 Legal and Business Toolkit (available here).… Continue Reading

NHSX Consults on Draft Digital Health Technology Standard

On February 27, 2020 NHSX, the technology and digital unit of the NHS, published its draft Digital Health Technology Standard (the “Standard”) for consultation to stakeholders in the digital health space (the “Consultation”). The Consultation is open until 22 April, 2020 (and is available here). The Standard, which is based on existing industry and health … Continue Reading

New Report Recommends Putting Public Engagement at the Heart of NHS Health Data Strategy

The Institute of Global Health Innovation at Imperial College London has published a report called “NHS data: Maximising its impact on the health and wealth of the United Kingdom” (the “Report”).[1] The Report begins from the premise that the knowledge gleaned from the combination of patient health data and “big data” technologies has incredible potential … 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

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 2015), contributed to the development … Continue Reading

FDA Announces Public Workshop on Using Randomized Clinical Trials to Generate Real-World Evidence

Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.”  This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in this post. According to … Continue Reading

Update: HHS Extends Comment Period for Interoperability Proposed Rules

On April 19, 2019, the Department of Health and Human Services (HHS) announced a 30-day extension to the comment period for two rules proposed by the HHS Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), originally published on March 4, 2019. These rules, discussed … Continue Reading

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
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