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MedTech Outlook | Thursday, March 16, 2023
Medical devices have the potential to revolutionise healthcare delivery, but data privacy and security measures must be in place to protect patient information.
FREMONT, CA: The EU's innovative health data space is being praised for its potential to revolutionise the medical devices industry, but its successful implementation poses difficulties related to regulatory issues and the protection of confidential business information.
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In May of last year, the Commission proposed the creation of a European Health Data Space (EHDS) which is currently being debated by EU policymakers. This proposal aims to address the challenges posed by the limited use of digital health data in the EU due to the varying standards among member states and the limited interoperability of this data.
The EU executive's goal is to establish a new governance framework for health data, which includes cross-border interoperability requirements and a pan-European infrastructure.
The aim of EHDS is not to create a centralised European database. Instead, the EHDS will introduce common standards that enable member states to digitise their healthcare systems in a manner that is most effective for their respective needs.
EHDS will facilitate the development of innovative life-saving treatments, medical devices, and next-generation medicines. Additionally, it will help to advance the adoption of personalized medicine and artificial intelligence in healthcare. Its impact on the healthcare sector may vary, as some fields such as medical devices are already collecting and utilising health data, for example, from diagnostic imaging or cardiac electrical monitoring.
In February, the EU association of medical device manufacturers published a position paper as a contribution to the ongoing discussions among policymakers regarding EHDS. This dossier is one of the last health-related files that could be finalised before the end of the current legislative mandate in 2024. Data sharing has the potential to revolutionise how we utilise data and shape its future, particularly for patients, as it can unlock numerous benefits.
Sitting on a Goldmine
The implementation of the EHDS is projected to result in substantial cost savings. For example, EU nations currently spend 1.4 billion Euros each year on medical images, and it is estimated that 10 per cent of these images are unnecessary. EU’s true objective is to release the health data economy by fostering the growth of current digital health services and products. Generating an EU-wide market for electronic health records could be feasible, once the standards and specifications are accessible in all member states.
That's true, with the rise of technology, one can generate an enormous amount of health data every second. Europe cannot continue to possess a valuable resource without the ability to acquire it. Medical devices and diagnostic companies are in a favourable position with many valuable resources available. The interconnectivity of medical equipment has the potential to gather data on various bodily functions like heart rate and body temperature, as well as track the efficacy of different therapies.
With considerable expertise in generating large volumes of data and possessing established numerous connections to facilitate the aid in the construction of the EDHS.
The Internet of Medical Things (IoMT) is not limited to only health-related data but also includes valuable information regarding the medical device's status, such as battery levels. This information could assist software developers in creating innovative applications and health service providers in developing new products.
Generating a virtuous cycle because much has already been established, underscores its significance.
Challenges Ahead
The new revolution has shaken the field of medical devices, and the renovation of the Vicennial regulatory framework for registering the products.
In 2017, the new rules launched into force and were started applicable from May 2021. It was in need that all medical devices produced in Europe had to be reaccredited. There weren't sufficient notified bodies established to evaluate compliance with the new regulations, which could have led to a shortage of these products. The resolution ultimately reached was to extend the transition period, allowing more time to adjust to the new rules. This proposal was put forward by the Commission and agreed upon by both EU ministers and MEPs.
The current regulatory framework for medical devices is already a comprehensive collection of regulations and obligations for our technologies. If new requirements were introduced, their interactions with existing regulations would also need to be thoroughly evaluated and taken into account.
For EDHS to achieve success, there should be active efforts to integrate and align all legislations involved, while also ensuring interaction with national legislation to avoid confusion, duplication, and fragmentation.
Another issue facing the medical devices industry pertains to safeguarding their intellectual property and confidential information related to trading secrets, particularly in cases of secondary use. This refers to the data generated and recorded during healthcare services or activities, which could potentially be utilised for purposes other than their original intent.
The proposed EHDS requires organisations that hold data to share it with other data users in the EU for secondary purposes, even if the data contains intellectual property or confidential information.
It is crucial to have a deliberate effort to share data, it should be done in a way that respects the existing laws governing trade secrets and intellectual property rights. These laws are in place for valid reasons, such as safeguarding innovation and trade and should not be ignored or undermined. Receiving intensive protection for IP rights and trade secrets will provide a stimulant for partnership and moulding the system's work.
Medical devices are poised to lead the way in harnessing the potential of health data as a valuable resource for improving healthcare outcomes. With the increasing availability of data from medical devices and wearables, healthcare providers have access to more comprehensive and real-time patient information, which can be used to personalise treatments and interventions. It is important to ensure that proper data privacy and security measures are in place to protect patient information. By leveraging the insights gained from health data, medical devices have the potential to revolutionise the way healthcare is delivered, resulting in better outcomes and a more efficient healthcare system.
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