Sarah Cowlishaw

Sarah Cowlishaw

Sarah Cowlishaw’s practice focuses on life sciences regulatory and commercial law for pharmaceutical, medical device, food, and consumer products. Her advice on general regulatory matters includes borderline determinations, food classifications, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion. Ms. Cowlishaw also advises on regulatory aspects of corporate/commercial deals, particularly regulatory due diligence.

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EU Medical Device Coordination Group Publishes Guidance on the Qualification and Classification of Software under Upcoming Medical Device Regulations

The EU’s regulatory rules for medical devices are due to change on 26 May 2020, when the new Medical Device Regulation (“MDR”)[1] comes into effect.  The regime for in vitro diagnostic devices will change two years later from 26 May 2022 when the In Vitro Diagnostic Devices Regulation (“IVDR”)[2] will apply. In advance of these … 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

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 a national regulator … Continue Reading

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 Updated Standards were produced following feedback … 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

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

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 … Continue Reading

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 … Continue Reading

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. … Continue Reading
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