EU regulators outline action plan to harness social media for real-world evidence in regulatory decisions

A report from HMA/EMA highlights social media’s transformative role in real-world data (RWD) for regulatory decisions, proposing a seven-point action plan to establish its value and enable its use in medicine regulation.

Social media platforms have become more than just spaces for communication; they now play a significant role in healthcare, offering a wealth of RWD that could be transformative for regulatory decision-making. An expert review report for the HMA/EMA Big Data Steering Group (BDSG) in 2024 outlines the potential uses, challenges, and opportunities of social media data in European medicines regulation.

The report, ‘Social Media Data for Real World Evidence in Regulatory Decision Making’, reviewed 73 relevant scientific articles and reviews identified through a literature search on the Embase database. These findings were used to formulate a set of regulatory use cases for social media data and to identify relevant challenges and opportunities. The report proposed seven key points for future action to establish the value of social media data and integrate it into medicine regulation.

Social media’s unique value in healthcare

Social media platforms such as Facebook, PatientsLikeMe, and X (Twitter) host diverse health-related discussions, ranging from disease management to treatment outcomes. As the report notes,

“Large amounts of patient data are currently present on social media platforms, which could be beneficial for regulatory decision-making.”

These data include patient demographics, patient experience data (PED), and real-time discussions on drug use, providing insights that traditional sources might not capture.

A significant opportunity lies in detecting adverse drug reactions (ADRs) and monitoring drug safety. The report highlights, “social media data is useful for early detection of potentially unsafe products for patients,” with some ADRs identified on social media months or even years before formal regulatory labeling changes.

Another promising use is in public health emergency response preparation. Social media proved valuable during the COVID-19 pandemic, with platforms enabling, “Rapid and near real-time insights into associated challenges,” such as tracking the spread of the virus and its impact on mental health.

Challenges to integrating social media data

Despite its potential, social media data poses challenges for regulatory use. The report emphasizes the issue of data completeness, noting that, “patients may not describe the medication to a sufficiently granular level,” or may omit key details like medical history and demographic information. The presence of bots, reposted content, and inaccurate data further complicates analysis.

Ethical considerations and privacy concerns are critical. The report underscores that, “the secondary use of patient data posted online is coated with complex ethical considerations,” including risks of re-identification and unclear patient consent.

Access to social media data has also become increasingly restricted. “Platforms like X and Facebook, which have been the go-to sources of social media data for research... have now blocked free access or drastically reduced the number of users’ posts available,” the report states. This limitation underscores the need for new strategies to secure reliable data access.

Pathways forward

To realize the full potential of social media data in regulatory decision-making, the BDSG emphasizes the need for focused initiatives and collaborations. Among its recommendations is the launch of proof-of-concept studies to assess social media’s utility across various regulatory applications. Ethical considerations are central, with a call for, “guiding principles for the ethical use of social media data in regulatory decision-making.”

Collaboration with stakeholders, including patient organizations, healthcare professionals, and industry, is deemed critical. The report highlights, “patient involvement is urged in the development of guiding principles,” ensuring alignment with public trust and expectations. Social media platforms also provide a vital source of PED, which can enrich insights into treatment impacts and unmet needs.

The report proposes seven key actions to establish the value of social media data:

1. Expedite access to social media data: Develop pathways to access data via private companies or regulatory collection efforts, potentially leveraging AI for data mining.
2. Increase discoverability of RWD studies and sources: Update catalogues to include filters for social media data, making studies and sources easier to find.
3. Engage and collaborate with stakeholders: Partner with patient organizations, healthcare professionals, and industry to leverage expertise and access targeted data.
4. Draft ethical guiding principles: Develop principles to address privacy, consent, and re-identification risks, prioritizing publicly available data.
5. Launch proof-of-concept studies: Pilot projects to explore social media’s utility in areas like orphan drug assessments, pediatric medicine, and public health emergencies.
6. Develop analytical methods: Support projects to validate and refine methods for analyzing social media data.
7. Host stakeholder workshops: Organize workshops to align stakeholders and establish a roadmap for incorporating social media data into regulation.

Social media holds immense potential as a source of RWD for regulatory purposes, from ADR detection to understanding unmet medical needs. By addressing challenges such as data quality, ethical use, and accessibility, regulators can harness these platforms to enhance patient safety and support evidence-based decisions. As the report highlights, social media offers

“A valuable tool to support crisis preparedness and identify information of high interest to public health.”