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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 for “transformative …impact” on patient health, scientific advancement and the UK’s economy. However, the Report argues that the current efforts of scientists, medical professionals and the UK government to develop the UK’s capacities are not sufficiently coordinated to maximise that potential. To address this, the Report presents a single, high-level, strategic framework for the collection, governance and use of patient health data in the NHS.
Continue Reading New Report Recommends Putting Public Engagement at the Heart of NHS Health Data Strategy

Following on from the Evidence Standards Framework for DHTs published in December 2018 (the Original Standards, as reported in our previous blog post, here), the UK’s National Institute for Health and Care Excellence (NICE) recently published a newly updated version of the standards (the Updated Standards, available here).

The

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 the meaning of ‘big data’ within the medicines regulatory context, defining it within the report as: “extremely large datasets which may be complex, multi-dimensional, unstructured and heterogeneous, which are accumulating rapidly and which may be analysed computationally to reveal patterns, trends, and associations. In general big data sets require advanced or specialised methods to provide an answer within reliable constraints”.

The Taskforce was split into seven sub-groups, each focusing on different categories of datasets:

  1. Clinical trials and imaging;
  2. Observational (or ‘Real World’) data;
  3. Spontaneous adverse drug reports (ADR);
  4. Social media and mobile health;
  5. Genomics;
  6. Bioanalytical ‘omics (with a focus on proteomics); and
  7. Data analytics (this work is ongoing and cuts across the above six sub-groups; a further report is expected in Q1 2019).

The sub-groups were each asked, amongst other thing, to characterise their respective datasets; consider the specific areas where big data usability and applicability may add value; assess the existing competencies and expertise present across the European regulatory network regarding the analysis and interpretation of big data; and provide a list of recommendations and a ‘Big Data Roadmap’.


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

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

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 in order to allow a combined analysis across several databases/datasets”. The report follows an EMA-hosted workshop in December 2017 to examine the opportunities and challenges of developing a CDM.

The report acknowledges that the use of ‘Real World Data’ (RWD) (data relating to patient health status or delivery of health care data that is routinely collected from sources other than clinical trials) has become an increasingly common source of evidence to support drug development and regulatory decision making for human medical use in Europe. However, Europe currently has no pan-European data network, despite the wealth of data generated through various national healthcare systems that provide access for all. Many multi-database studies currently performed are typically slow and still allow for substantial variability in the conduct of studies. Further, there are a growing number of innovative products that no longer align with customary drug development pathways. This may create uncertainty in their data packages required for authorization, and subsequent tension between facilitating earlier access for patients with limited treatment options against the requirement for proactive robust pharmacovigilance of medicines for wider clinical use across the product life cycle (the existing EMA Patient Registry Initiative addresses this need in part).
Continue Reading EMA publishes “A Common Data Model for Europe? – Why? Which? How?” Workshop Report

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 advantage of the continuing digitisation and integration of technology, often referred to as the Fourth Industrial Revolution (“4IR”).

To facilitate this change the Paper outlines three key targets that should be set by the Department of Health and Social Care, to be achieved by 2028:

  1. Move the NHS to a “digital first” platform and to aim to ensure that all interactions within the health service are digitally driven.
  2. Build an ecosystem of apps and innovation within and around the NHS, to improve patient service and control.
  3. Ensure that the savings made from automation and innovation are put back into frontline services and that budgets for staff R&D and technology training rise in line with overall NHS spending.


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

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 to and sharing of health data

The Commission wishes to ensure that EU citizens should have secure access, anywhere in the EU, to a comprehensive electronic record of their health data. Citizens should remain in control of their health data (wherever it is located) and be able to share it securely with others for purposes chosen by those citizens, for example, medical treatment or research.

The Commission recommends the:

  • development and adoption of a “European electronic health record exchange format”, which would expand the existing eHealth digital services infrastructure; and
  • establishment of interoperable standards that would minimise barriers to cross-border transfer of health information and data within the EU and identify incentives for adopting the common format, and tackle practices that impede interoperability.


Continue Reading Summary of the European Commission’s eHealth Strategy

On 14 September 2017, the Committee for Human Medicinal Products (“CHMP”) of the European Medicines Agency adopted ICH Guideline E18 (the “Guideline”) on genomic sampling and the management of genomic data.  The Guideline takes effect on 28 February 2018.

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) developed the Guideline in acknowledgement of the growing awareness of, and interest in, genomic data generated from clinical studies.  The ICH suggested that the absence of a harmonized guideline made it more difficult to conduct genomic research consistently in global studies.  The fact that the CHMP has adopted the Guideline means that EU guidance on this subject is now aligned with the ICH standard.

The Guideline provides general principles for the collection and handling of genomic samples and management of genomic data.  It also affirms broader principles, such as the need for informed consent and the protection of subjects’ privacy etc.  The Guideline applies to both interventional and non-interventional clinical studies, irrespective of when the genomic research is carried out and whether it was envisaged in the study protocol.  The ICH/CHMP intend the Guideline to be interpreted in accordance with the law and policies in each jurisdiction where genomic research takes place.
Continue Reading CHMP Adopts Guideline on Genomic Sampling and Management of Genomic Data

Digital Health

In the second of a three-part series, Covington’s global cross-practice Digital Health team considers some additional key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle.

Key Commercial Questions When
Contracting for Digital

Digital Health

In the first of a three-part series, Covington’s global cross-practice Digital Health team answers key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle.

Key Regulatory Questions About Digital Health Solutions

1. What