On February 10, 2020, the UK Government’s Committee on Standards in Public Life* (the “Committee”) published its Report on Artificial Intelligence and Public Standards (the “Report”). The Report examines potential opportunities and hurdles in the deployment of AI in the public sector, including how such deployment may implicate the “Seven Principles of Public Life” applicable to holders of public office, also known as the “Nolan Principles” (available here). It also sets out practical recommendations for use of AI in public services, which will be of interest to companies supplying AI technologies to the public sector (including the UK National Health Service (“NHS”)), or offering public services directly to UK citizens on behalf of the UK Government. The Report elaborates on the UK Government’s June 2019 Guide to using AI in the public sector (see our previous blog here).

Continue Reading UK Government’s Advisory Committee Publishes Report on Public Sector Use of AI

In this final instalment of our series of blogs on the European Commission’s plans for AI and data, announced on 19 February 2020, we discuss some potential effects on companies in the digital health sector. As discussed in our previous blog posts (here, here and here), the papers published by the European Commission cover broad concepts and apply generally — but, in places, they specifically mention healthcare and medical devices.

The Commission recognizes the important role that AI and big data analysis can play in improving healthcare, but also notes the specific risks that could arise given the effects that such new technologies may have on individuals’ health, safety, and fundamental rights. The Commission also notes that existing EU legislation already affords a high level of protection for individuals, including through medical devices laws and data protection laws. The Commission’s proposals therefore focus on addressing the gap between these existing rules and the residual risks that remain in respect of new technologies. Note that the Commission’s proposals in the White Paper on AI are open for public consultation until 19 May 2020.


Continue Reading European Commission’s Plans for AI and Data: Focus on Digital Health (Part 4 of 4)

On 19 February 2020, the new European Commission published two Communications relating to its five-year digital strategy: one on shaping Europe’s digital future, and one on its European strategy for data (the Commission also published a white paper proposing its strategy on AI; see our previous blogs here and here).  In both Communications, the Commission sets out a vision of the EU powered by digital solutions that are strongly rooted in European values and EU fundamental rights.  Both Communications also emphasize the intent to strengthen “European technological sovereignty”, which in the Commission’s view will enable the EU to define its own rules and values in the digital age.  The Communications set out the Commission’s plans to achieve this vision.

Continue Reading European Commission’s plans on data and Europe’s digital future (Part 3 of 4)

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

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 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’

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

The UK Government has opened a consultation, running until September 7, 2016, regarding how UK National Health Service (NHS) patient data should be safeguarded, and how it could be used for purposes other than direct care (e.g. scientific research).

The consultation comes after two parallel-track reviews of information governance and data security arrangements in the NHS found a number of shortcomings, described below.  The  Care Quality Commission (CQC) and the National Data Guardian (NDG, led by Dame Fiona Caldicott) made a range of recommendations, including new security standards, stronger inspection and enforcement around security lapses and re-identification of anonymized patient data, and an eight-point process around assuming and respecting patient consent decisions.

Following the public consultation, the new security standards could eventually be required and audited by government inspectors from the CQC, and imposed under revised standard NHS England contract terms.  CQC inspectors could potentially act on tip-offs from NHS Digital (formerly known as the NHS Health and Social Care Information Centre, ‘HSCIC’).  Those tip-offs could be based on low scores obtained by organizations in their annual NHS Information Governance Toolkit (IGT) self-assessments.  The IGT, which the reviewers said should be redesigned, applies both to NHS bodies and their commercial vendors.

The new consent model, meanwhile, could provide more streamlined, system-wide consents for use of patient data for purposes including quality assurance and research.

The CQC and the NDG’s findings and twenty-four recommendations were jointly presented in a covering letter to the UK government, available here, and fuller reports, available here and here (CQC and NDG, respectively).  This post provides a brief summary of their main findings and recommendations.  For the consultation questions themselves, see here.
Continue Reading UK Government Considering New Patient Data Security and Research Consent Standards, Sanctions