Digital Services Act package
According to the Opinion of the European Commission Expert Panel on Health, it is expected that the impact of digitalization on health, healthcare delivery and health systems, can and will likely be profound. In particular, health services have already undergone digital transformation which impacts healthcare delivery.
On 19 February 2020, as part of the European Digital Strategy, the European Commission announced a Digital Services Act package to strengthen the Single Market for digital services and foster innovation and competitiveness of the European online environment across all sectors. The European Commission will publish its proposals in the 4th
quarter of 2020.
The new Digital Services Act package is expected to modernise the current legal framework for digital services by means of two main pillars:
- the Commission would propose clear rules framing the responsibilities of digital services to address the risks faced by their users and to protect their rights. In this regard, the European Commission is planning to review the e-Commerce Directive (Directive 2000/31) in order to adapt it to the new realities and technology developments. The legal obligations are expected to improve the cooperation system for the supervision of platforms and guarantee effective enforcement.
- the Digital Services Act package would propose ex ante rules covering large online platforms acting as gatekeepers. The initiative should ensure that those platforms behave fairly and can be challenged by new entrants and existing competitors, so that consumers have the widest choice and the Single Market remains competitive and open to innovations.
September 2020, PGEU contributed to the EU consultation on the Digital Services Act (DSA) and published a position paper raising community pharmacists’ concerns on the impact of the DSA package on the online provision of medicines, particularly in a cross-border context.
PGEU believes the Digital Services Act should first and foremost tackle unsafe and illegal products available online, including medicinal and healthcare products, as these are increasingly present online and clearly threaten consumers.
Big Data & Artificial Intelligence
The shift towards the digital economy has accelerated the pace at which new technologies are transforming the healthcare sector.
Community pharmacists acknowledge the potential of Big Data and Artificial Intelligence (AI) for European health systems and consider these technologies as a useful tool to support healthcare professionals. In routine practice at national level, these tools shall be always accompanied by pharmacists’ expert and professional advice, in order to improve workflow efficiency, while promoting therapy effectiveness and offering the highest standard of pharmacy services to its patients.
In the era of digitalization, community pharmacists remain a trusted source of reliable and independent health information for patients, by making the innovative digital solutions integral to community pharmacy services.
On 20 February 2019, PGEU published a Position Paper on ‘Big Data and Artificial Intelligence in Healthcare’ with the aim to show how community pharmacists are equipped to address the challenges and opportunities arising from digitalization in healthcare. The paper also provides key policy recommendations to take full benefit of the potential of Big Data and AI in healthcare and promote sustainable and resilient health systems in Europe.
On 10 September 2020, PGEU contributed to the consultation on the European Commission Roadmap on the ethical and legal requirements for Artificial Intelligence in Europe.
In 2021, PGEU welcomed the European Commission’s Proposal for an EU Regulation on Artificial Intelligence (AI Act). PGEU supports the European Commission’s general objective to ensure the development and uptake of AI across the Single Market is conducted in a trustworthy way and submitted its feedback on the proposal in July 2021.
Today, many pharmacists use eHealth tools on a daily basis, whether it is dispensing electronic prescriptions, checking for medication interactions when accessing electronic medication records, providing support for adherence via a mobile app or telephone call, or acting as the patient’s entry point into the health system. eHealth tools used in community pharmacies can be considered under the following themes.
On the 17th of November 2016, the Pharmaceutical Group of the European Union approved a Statement on eHealth recommending (1) to engage with pharmacists as experienced users to develop eHealth policies and services at local, regional or national levels; (2) to integrate eHealth into health systems so it complements and supports existing practice; (3) link electronic health records with ePrescribing systems; (4) and improve communication and collaboration between patients, healthcare professionals and ICT developers to obtain the full potential of eHealth technologies and build confidence and trust. Additionally an Annex of Best Practices from PGEU members was published (please see below).
eHealth and European Policy
On behalf of European community pharmacists, PGEU has been involved in a number of consultations and initiatives at European level. In June 2014 in our response to the European Commission’s “Green Paper on mHealth”, PGEU called for better protection of data generated by mHealth apps and asked the Commission to develop Guidelines in connection with the lifestyle app/Medical Device distinction. Additionally, the PGEU called upon developers to ensure end users or facilitators of eHealth products (i.e. patients and healthcare professionals) are consulted during the design, evaluation and implementation phases to ensure they are fit for practice.
PGEU has previously been a partner in the former EU eHealth Network Governance Initiative (eHGI) Joint Action, in particular contributing to the development of the Guidelines on ePrescriptions Dataset for Electronic Exchange under Cross-border Directive 2011/24/EU.
PGEU is also an active member of the European Commission’s eHealth Stakeholder Group (eHSG).