New and innovative technologies have led to a huge increase in data coming from sources that haven’t previously been used within the regulated medicines industry. In recognition of this explosion of data and the associated technological advances the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) joint subgroup has released a report on Social Media and mHealth data, which encourages a collaborative approach and emphasises the need for a clear regulatory roadmap to tackle the challenges presented by the use of data derived from evolving technologies. A full copy of the report, setting out the actions and goals against the recommendations made can be accessed here.
Core to the report are the defined but continually evolving concepts of “social media” and “mHealth”, which are ascribed the following meanings:
- ”Social media” – Internet-based tools which facilitate the gathering of individuals and communities to communicate and share information, ideas and experiences in real time.
- “mHealth” – the use of technology to facilitate data collection which supports self-management, clinical care and research, and eventually to improve outcomes including through the use of digital interventions. mHealth includes forms of social media that facilitate healthcare and medicine but also embraces standalone devices and apps used on portable electronic devices.
The objectives of the report are as follows:
- To identify, characterise, and evaluate how data available from social media sites and mHealth technologies could support decision-making in regulating medicines;
- To identify stages in a product lifecycle where such data could facilitate or enhance regulatory decisions and challenges for regulators; and
- To advance recommendations so as to address the regulatory challenges that the use of such data brings.
The recommendations and reinforcing actions made to support regulators in the optimal use and understanding of datasets arising from social media and mHealth include:
- Social media data access and use: to identify opportunities for regulators to access data from social media companies, and to collaborate with certain platforms in gathering or stimulating new qualitative and quantitative patient data. In line with this recommendation, the reinforcing actions also include the creation of guidance around the ethical, moral and legal implications of pharmaceutical companies using social media data.
- Communication of regulatory information via social media: to develop an understanding of how behavioural science can contribute to sharing regulatory recommendations on medicines through social media, to be more effective and ensure changes in clinical practice.
- Effective regulation of mHealth devices:to liaise with medical device regulators to ensure effective regulation of devices which generate data submitted to medicine regulators, so that the differing regulatory frameworks can work in tandem.
- Data validation for mHealth devices: to facilitate the use of mHealth devices in research surrounding medicine safety and efficacy by ensuring data quality. This should be done by setting out the different types of mHealth datasets against potential uses to define the extent and type of validation required.
- mHealth data in clinical trials and reported outcomes: to review uses of mHealth data in clinical trials to ensure medicine regulations are prepared for the submission of clinical trial data and facilitates the collection of mHealth data. It is hoped this will increase the clinical applicability and relevance to patients of evidence available on the efficacy of medicines.
- App development: to continue to develop apps which can gather data from patients, encouraging their adoption and also building an understanding of how apps and other mHealth devices can be used to mitigate risks and support self-management in patients.
The report recognises that in both social media and m-health, a collaborative approach needs to be taken by various sectors, from medical researchers and pharmaceutical companies, to data protection authorities and technological partners reflective of the fast-moving and continually evolving technologies and methods engaged. In particular, collaboration with academic circles and technology companies will be pivotal due to the technical expertise required and particular consideration should be given to providing regulatory guidance on the collection, validation and analysis of data from such apps and devices.
Whilst a variety of complex challenges will inevitably be faced, from data security and data reliability to, the durability of devices and ethical questions, it is hoped that the incentive of global benefits of new data collection and processing tools, in tandem with the geographical reach and power of social media, will help overcome these.
Article co-authored by Eleanor Furlong.