Tjasa Zajc

Using 14 key performance indicators (KPIs), decision-makers receive an overview of surgeon performance. This increased transparency aims to enhance the quality of care and identify potential areas for improvement.

A harmonised European Health Technology Assessment Regulation (HTAR) is set to come into force in 2025, but the mandatory application of the regulation does not cover digital health technologies. The EDiHTA Project aims to address that.

To build trust in technology, healthcare workers and patients must understand it. Prof. Dr. Georgi Chaltikyan advocates for micro-courses and digestible educational content.

People respond differently to medications. Prescribing could be optimised through pharmacogenomic testing, which could reduce medication waste, notes Clinical Innovation Lead for the University of Manchester Videha Sharma.

Digital transformation of healthcare not only requires investments in digital technology, but also in digital health literacy. This must be coordinated across three critical levels: individual, institutional and policy-making.

Christine Antorini, former Danish education minister, believes that innovative education and job strategies could harness a growing interest in healthcare careers. She began nursing at 58.

Digitalisation in healthcare holds the promise of optimising processes and expanding access to care. In some European countries such as Slovenia, Croatia, Estonia, Poland and Hungary, patients can access national portals that contain their prescriptions, referrals, discharge letters, etc. In other countries such as Belgium and Spain, patients can access regional portals. In the Netherlands, Germany and Switzerland, individual healthcare providers offer their own patient portals. This means if a person visits multiple facilities, they must use different portals to access their health data. The European Health Data Space (EHDS) legislation aims to improve access to and control by individuals of their electronic health data, expand healthcare data accessibility across borders, and use healthcare data for patient acute care and research. The range of changes tech could in theory bring to healthcare is extensive, including the following: Faster access to and improved coordination of care by having a more direct channel with clinicians through an online portal. Time saved by opting for telemedicine over an in-person visit. More precise diagnoses with the help of AI. Reduced burden on frontline staff due to tech-enabled capacity optimisations. On the dark side, there are patient concerns: Will my data be exploited? Is it safe? Will I lose the connection with my doctor? After all, people, especially those in vulnerable health situations, crave human touch and a reassuring voice. What do patients worry about? The European Patients' Forum is an umbrella organisation of patient organisations across Europe, with its 79 members including disease-specific patient groups active on the EU and national levels in Europe. Patients have a number of concerns about the digital transformation of healthcare, according to Gözde Susuzlu Briggs, programme manager at the European Patients' Forum:  Digitalisation could exacerbate existing health inequalities, especially where there is a significant digital divide. There is a risk of unauthorized access to or breaches of patients' personal health information (PHI). A lack of interoperability is hindering effective care. There are worries about the affordability and accessibility of digital health solutions. The shift to digital health requires an adjustment in how patients interact with healthcare systems. It is very difficult to stay on top of innovation in digital health. "Patient communities know their disease areas quite well, but in terms of other advanced technologies or work that's around legislations and legal frameworks are topics that are quite new unless it's their profession," Briggs said. Improving digital literacy and involving patients in the development of solutions are crucial for building public trust and ensuring a positive user experience. Education, explanation, collaboration On the EU level, several organisations work with and for patients on inclusion in data management and improving digital literacy. Non-profit organisation EUPATI (European Patients Academy on Therapeutic Innovation) provides education and training to increase the capacity and capability of patients and patient representatives in medicines R&D. In 2023, EUPATI designed a Digital Health module that provides an overview on digital health and its regulatory framework. "Based on the feedback so far, real-world evidence and real-world data seem to be specific areas where patients struggle to fully understand their role and relevant opportunities for involvement," said Maria Dutarte, executive director at EUPATI. More workshops and … national marketing? "I haven't yet met a patient who wants all their healthcare from a computer, including myself," said Kristof Vanfraechem, founder and CEO of Data for Patients – a European organisation focused on bringing data/digital experts who are also patients/caregivers into strategic change initiatives. "We see digital as an opportunity to enhance human healthcare – tools to bring the humans – frontline workers and patients – closer together more efficiently and effectively to get or, even better, keep patients as healthy as possible at all times," he said. Vanfraechem emphasized that digital transformation is a complex change at the society level. Data for Patients invests in supporting patient organisations in an approach close to them. Education and awareness may seem to be a straightforward solution to increasing knowledge, managing expectations about digitalisation in the patient population, improving utilization of solutions and decreasing unnecessary tech-related fears, but someone needs to do the groundwork. Since not all patients are deeply involved with patient organisations, this leaves many responsibilities to decision-makers implementing and introducing new digital solutions. Laws and regulations are only a starting point for successful digital transformations. Gözde Susuzlu Briggs is the programme advisor for the "Empowering Patients" track at the 2024 HIMSS European Health Conference & Exhibition, which is scheduled for 29-31 May 2024 in Rome. Kristof Vanfraechem is moderating the session "Leveling Up! Harnessing Health Literacy to Achieve Equity." Learn more and register.

2023 was the year marked by AI. With the rise of general-purpose large language models ChatGPT, Claude and Bard, AI has become tangible and accessible for millions of people. There was no shortage of excitement, but also appeals for regulation of this powerful technology.  State of AI Regulation in Healthcare The EU AI Act was drafted already in 2021, long before the availability of general-purpose large language model. In December of 2023 a consensus on legislation seemed to have been achieved. Across the pond in the US, under the Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, Health and Human Services (HHS) needs to establish an AI Task Force which will need to develop a regulatory action plan for predictive and generative AI-enabled technologies in health care in 2024. Regulation is always a step behind the industry and setting rules for healthcare isn’t possible without the tech industry and medical recommendations. There seem to be more and more associations forming every day. There’s the US Coalition for Health AI (CHAI™) -  a community of academic health systems, organizations, and expert practitioners of artificial intelligence (AI) and data science. It proposed a setup of special assurance labs that would allow health systems as well as tool developers and vendors to submit their AI solutions for evaluation. The New England Journal of Medicine launched NEJM AI, a monthly, online-only publication for evaluating applications of artificial intelligence in clinical medicine. The Global Agency for Responsible AI in Health strives to harmonize global healthcare standards as defined by WHO. The organization wants to connect different regulatory bodies from around the world and create early warning systems. These would notify the network if unintended effects of AI were detected anywhere in the world. The ideas are there, but it will take time for them to take form.  AI Regulation in the EU will be felt after 2026 The official EU AI legislative document is expected early in 2024. Till then, the experts are cautious and also critical, especially in regards to open-source AI and proprietary model regulation. „Our information about the EU AI regulation stems from leaks in the negotiation process which was marked by opacity and lack of democracy oversight. Right now, anti-open source lobbyists are trying to mess with the Act after the deal, all because they're upset about the rumor that open-science based AI R&D might be exempt from regulations. I and most other AI experts advocate that regulations should only come into play at the application level. Going beyond that would suppress scientific freedom and undermine the European advantage,“ says Bart de Witte, Founder of HIPPO AI Foundation, which advocates for the development of open-source AI, to prevent consolidation of power in the hands of global tech corporations.  EU AI Act could be disrupted by countries like France and Germany who prefer self-regulation and want changes to the legislation. Ricardo Baptista Leite, CEO at The Global Agency for Responsible AI in Health sees this as problematic: “In highly sensitive areas like health, I don't believe this is necessarily the best approach. It depends on the application of the AI, but at the end of the day, these countries are opening up a whole can of worms of discussions, which can undermine the process moving forward.”  The upcoming European elections may also steer the conversation, as shifts in political power could influence the act's implementation. “We have the country level approach that with the rise of extreme nationalisms could lead to very, very poor policies that can undermine all the efforts of trying to find some level of harmonization. Harmonization is critical to ensure that these technologies can be used in a safe manner, but also in a way of us making sure that we're uptaking the most of the technology’s potential,” says Ricardo Baptista Leite and explains that while the AI Act is a step forward, the real impact on industries, particularly health, won't be felt until around 2026. The next two years are going to be crucial for balancing the risks and harnessing the benefits AI brings to health systems and patient care.  How Can Industry Scale? The Global Agency for Responsible AI in Health, will advocate for the same principles that we have for medicines approval and health technology assessment to be used for AI in healthcare. In the future, the Agency plans to create a comprehensive AI solutions repository. This platform will focus on health AI, providing an online public database. It will be a global showcase, featuring AI technologies validated by various countries. More of these topics will be discussed at HIMSS24 Europe, which will have a dedicated AI track.