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
French medicines regulator produces first in Europe medical devices cybersecurity guidelines
France’s medicines regulator, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), has released draft guidelines, currently subject to a public consultation, setting out recommendations for manufacturers designed to help prevent cybersecurity attacks to medical devices. Notably, the draft guidelines are the first instance of recommendations released by
UK’s NICE releases newly updated Digital Health Technologies (DHT) Evidence Standards Framework
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
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 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:
- Clinical trials and imaging;
- Observational (or ‘Real World’) data;
- Spontaneous adverse drug reports (ADR);
- Social media and mobile health;
- Genomics;
- Bioanalytical ‘omics (with a focus on proteomics); and
- 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’.
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 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
Key Takeaways from Covington’s Webinar about Digital Health Associated with Pharmaceuticals
On February 1, 2018, Covington’s Digital Health team hosted a webinar examining U.S. and EU regulatory issues for digital health associated with pharmaceuticals. Here are some key takeaways from that webinar:
- Neela Paykel from Proteus Digital Health, noted that “you need to think outside the box for how to engage, whether you’re a pharma company
The Evolving FDA and EU Equivalent Regulation of Digital Health: A Device Perspective
On November 14, lawyers from Teva Pharmaceuticals and Covington & Burling discussed digital health innovation from a medical device regulation perspective in the U.S. and the EU. The presentation by Rachel Turow, Executive Counsel – Regulatory Law, Teva Pharmaceuticals, and Grant Castle, Scott Danzis, Sarah Cowlishaw, and Christina Kuhn of Covington, covered topics such as
AG Opinion on Software Medical Devices
On 28 June 2017, Advocate General Sanchez-Bordona (AG) presented his opinion in case C-329/16 Syndicat national de l’industrie des technologies médicales and Philips France following a request for preliminary ruling from the Conseil d’État (France) to the Court of Justice of the European Union (CJEU) concerning the laws governing the classification of software medical devices.