EU Regulatory and Litigation

Connected health involving health technology, digital media and mobile devices opens up new opportunities to improve the quality and outcomes of both health and social care. Such transformational innovation, however, may also bring about significant regulatory compliance risks.

On 3 March 2017, four UK healthcare regulators, including the Care Quality Commission (“CQC”), made a joint

We have previously published a post on the potential uses of mobile apps in clinical trials, and the accompanying advantages and limitations. Recent research published in The New England Journal of Medicine (NEJM) confirms the increasing number of innovative studies being conducted through the internet, and discusses the bioethical considerations and technical complexities arising from

The National Institute for health and Care Excellence (NICE) provides guidance to the NHS in England on the clinical and cost effectiveness of selected new and established technologies through its healthcare technology assessment (HTA) program. Using the experience it has gained from this program, NICE intends to develop a system for evaluating

We previously described some of the ways in which life sciences companies are exploring the potential of IBM’s supercomputer, ‘Watson®’, to assist with product development and disease treatment.  Such uses raise important questions about how Watson and other software are treated under medical device regulations.  These questions are particularly important as tech companies

Interoperability has been identified as one of the greatest challenges in healthcare IT. It is defined as the ability of organizations to share information and knowledge, by means of the exchange of data between their respective IT systems, and is about bringing to life fruitful collaborations between different healthcare environments, with electronic means.

With this

Updating our earlier blog post, ‘Next Up: European Consultation on the Safety of Apps’ that consultation has now closed and the Summary Report was published on November 14, 2016.

As previously explained, the consultation is one of a series of consultations and draft guidance through which the European Commission is seeking to develop

Improvements in the efficiency of clinical development is the highest priority for the innovative industry. And yet, costs associated with clinical trials, and delays in patient recruitment and retention, persist. Companies are continually on the look-out for ways of addressing these issues, and mHealth may be the answer. Digital technologies, and the integration of wearable

Last month, three life sciences giants announced new or deepening partnerships with IBM, to capitalize on IBM’s supercomputer, ‘Watson’, an artificially intelligent computer system. There has been a lot of buzz recently about how big data can be meaningfully applied in the healthcare setting to assist with product development and disease treatment.  The European Medicines

On October 2016, the Association of British Healthcare Industries (ABHI), with over 250 company members, published significant changes to its Code of Business Practice. While the ABHI Code represents a non-statutory scheme it is commercially important to be aware of its guiding principles in the company interactions with healthcare professionals and other customers and