There have been tremendous advances in digital health and medical intelligence (AI) that make the integration of these systems into healthcare irreversible. It is not surprising that biopharma, medtech and investors are trying to find another opportunity. Many factors are driving this growth, including the aging of the population, the rise of chronic diseases and the growing demand for personalized medicine.
Applications such as mobile health, telehealth, big data and electronic health systems can facilitate and facilitate the admission and retention of patients for clinical trials through remote monitoring devices and wearable devices and contribute to rapid diagnosis and the complexity of the data presented in the clinicaly evidence is valid.
Telehealth services ensure that more people can be diagnosed, evaluated and treated more quickly in a more personalized way. There are also important applications of AI tools in drug monitoring and reporting of adverse events and symptoms. On the one hand, the rise of digital medical systems helps health professionals and patients to better manage health outcomes and reduce hospital visits, thus reducing the overall burden on the health system.
As innovation grows louder, national administrators catch up. Inevitably, outdated or inappropriate laws and reimbursement systems may hinder the development of these new technologies and patient access to these new technologies, especially in the field of AI, medical devices , data privacy and cybersecurity.
This is especially important in the EU, where the European Commission has recently introduced several laws, including the AI Bill and the AI Product Liability Directive, which will regulate the use of AI in health. These proposals do not take into account how self-learning algorithms will be organized in the EU.
These errors mean that developers are left in the dark about what is required. Industry watchers have also criticized other aspects of the proposed measures as unnecessary burdens, which could duplicate existing products and have a negative impact on innovation.
The trust of patients and health professionals is an important condition for these procedures to be removed. EU legislative initiatives such as the AI product bill and new cybersecurity laws such as the NIS 2 directive will strengthen the security of the digital environment and address these concerns to make digital health more reliable and AI.
As many of the current conditions are changing, companies are advised to review developments and try to incorporate these factors into their products at an early stage - while placing the same conditions with partners their market. For companies based in the EU that want to enter the digital health and health AI market, it is important to be active in the regulated changes, passing many regulatory steps in the field medical devices and AI.
This may include requiring timely compliance with proposed regulations or compliance with regulatory authorities to ensure future compliance of products and services.
In order to remain positive, the UK decided to introduce standards that show consistent industry standards and guidelines for AI, but without clear rules about it. This may lead to breaches of EU law and practice and companies are advised to take this into account when revising their plans.
Given the possibility of a relationship with the EU, it may be important for Switzerland to interact with developments within the EU.
Switzerland intends to creat a program to promote a collaborative health system based on environmental data, reflecting the European concept of the European Health Data Space (EHDS). In view of future integration with European infrastructure, cooperation will be important.
Another important challenge facing the digital health industry and health AI is the need for a global system and compensation tailored to their goals. At the moment, there are big differences in how these technologies are rewarded from country to country, leading to confusion and uncertainty for companies working in this space, especially in the EU, where there is a patchwork national compensation system.
There is a growing interest in value-based care, in which health technology is rewarded based on outcomes, in an evidence-based manner. This will be reflected in the company's price and business model, which should be adapted to reflect the changes in the market, including how to measure the results and put their contributions into the health care system.
The need for global regulation and reimbursement for digital health and health AI is emerging as a way to make it easier for companies to enter the EU market and help ensure that patients can get the best care .
Despite these challenges, the prospects for digital health and health AI in Europe remain positive. Here are some important tips for companies looking to start up:
What sets digital health tools / AI medicine apart?
What real benefits does it bring to patients and the healthcare system? Can the solution be used fully?
Is it interactive, that is, does it integrate easily into the health care system? Does the company have all the necessary data to support their product value proposition?
What partnerships can help in the development and delivery of technology? What standards apply and which assessment firms are most appropriate for critical technology assessments?
Overall, the key to success in the digital health and health AI market will be the ability to adapt to organizational change and create the right business model. By doing so, businesses will be well positioned to take advantage of the many opportunities this rapidly changing market has to offer.