The COVID pandemic has led to a major surge when it comes to the adoption of digital health technologies. However, both patients as well as market players may occasionally feel that advancements and also investments in this field are not growing at a satisfactory pace. One reason for this is the fragmented legal landscape throughout the EU and other regions and the strict regulations governing the usage of health data.
What can one expect in 2024, a potentially groundbreaking year?
In the last few years, there have been numerous legislative and regulatory proposals that have affected the healthcare along with the life sciences sectors. These initiatives look forward to driving further reform in a sector that often lags behind when it comes to digital transformation. The goal for Health Tech happens to come up with an environment that makes use of artificial intelligence so as to provide safe solutions that elevate patient outcomes. The use cases happen to range from using big data algorithms within clinical studies to leveraging machine learning so as to assist healthcare professionals. Furthermore, these use cases go on to include aiding patients by way of robotics and improving efficiency in hospitals by executing AI-based tools. At the same time, there is optimism for a regulatory framework that goes on to reduce obstacles and also promotes the availability of patient data. In 2024, the health tech industry could go on to see significant growth because of various elements, such as the European Health Data Space, the EU’s draft AI Act, and several national initiatives.
The AI Act is anticipated to have enough influence on digital health within the European Union- EU
The AI Act- AIA, which is expected to come into effect in 2024, will go on to have a major impact on medical device companies that make use of machine learning technology. Additionally, it will also go on to have broader implications for the healthcare as well as life sciences industries. The objective is to keep confidence in EU citizens so they become more willing to adopt AI-based solutions like AI-enabled medical technologies.
The AIA will go on to cover all products that meet the definition of an AI system. AI-based medical software systems are going to be subject to regulation. The AIA, like the GDPR as well as the Medical Devices Regulation, embraces a risk-based approach. Compliance obligations with regards to the development and use of AI systems happen to be directly linked to the level of risk they may cause, which can be categorized as unacceptable, high, low, or even minimal.
In the healthcare or life sciences sectors, AI applications can be categorized as “high-risk AI systems.” In such cases, the most rigorous obligations will be applicable. These obligations include implementing a quality and risk management system, maintaining detailed technical documentation, and conducting a conformity assessment similar to those required for CE markings. Implementing this would impose a significant burden on healthcare companies within its scope, necessitating careful execution.
The AI Liability Act
The idea behind the EU’s AI Liability Act- ALA is to address a dearth of regulation in the field of AI. The AIA does not go on to provide direct protective rights for individuals; therefore, the ALA seeks to address this by offering individuals who are negatively impacted by an AI system the ability to take legal action. They look to achieve this by making it easier for individuals to bring forth their claims. As a result, it puts in place a new liability framework that begins with the underlying assumption that liability for AI is based on the presence of causality, which means that the affected person is not required to give out the connection between the damage caused and the use or output in terms of the AI system. The ALA- Artificial Intelligence Liability Act is still in its early stages, and it may take a while before it gets enacted and applied. But healthcare providers who make use of AI should consider the possibility of facing more litigation in the times to come. It is important for them to factor this in when it comes to their development and use of AI tech.
The European Health Data Space will make progress
The European Health Data Space- EHDS is the initial common European Data Space that was proposed by the EU. This proposal happens to be part of a broader initiative which is aimed at establishing shared data spaces for numerous sectors. The EU’s data strategy takes this as a crucial pillar. As explained in greater detail, the EHDS has the objective of creating a legal structure for accessing and sharing data while also ensuring the quality and interoperability of health data. Patients will have access to their own personal health data, and also healthcare professionals from different Member States will also be able to access electronic health records across borders.
The EHDS happens to be crucial for digital healthcare as it enables the downloading and utilization of anonymized health data, which can be used for various purposes, like training AI applications in the healthcare sector, as long as specific conditions are met. Apparently, the EU is not the only entity that is attempting to facilitate the sharing of health data in the way it is. For instance, the UK is at present conducting tests on secure data environments to access NHS data for research purposes and also for other external uses. There are even plans for a broader implementation in the future.
The EHDS is at present advancing through the regulatory process. The European Parliament and the Council are most likely to act on their compromise proposals very soon, possibly by the end of 2023. The EHDS is anticipated to be finalized next year, but it is unlikely to become completely operational before 2025, based on how things progress.
It is well to be noted that Germany will maintain its position as a frontrunner in the regulation of digital health.
The country is currently working on multiple legislative initiatives to establish an absolute and legally sound framework so as to access as well as share health data. Two significant acts which happen to be the Digital Act and the Health Data Use Act, are expected to come into effect in February of next year.
