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    E-Health: How to enter this market full of opportunities and legal challenges?

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  • Hospitals are gradually moving towards more comprehensive software systems for their day-to-day operations. However, new innovative apps and tools are not yet able to integrate fully with these systems, which causes problems for many operations like communication with patients. Opening up the systems and enabling easy data exchange through the use of API’s could be the solution. Why is this alignment key to success in the e-health industry?


    The IT landscape in the medical sector is growing rapidly. For a long time, Dutch hospitals have been using comprehensive software systems for managing their healthcare, operational, and financial processes. These comprehensive software systems have become the hospitals’ essential facility for managing both hospital data and patient data. However, efficiency can often still be improved, and for direct information flows to patients, their relatives and other interested parties, the current systems are only showing first signs of ‘customer’-facing functionality.

    More recently, startups and other disruptors entered the ‘e-Health’ market with innovative apps and tools that promise to increase process efficiency and patient satisfaction in areas such as health surveillance, scientific research but also primary healthcare itself. The medical sector lends itself to these innovative, cost-effective and process-improving solutions. At the same time, trying to integrate these new apps and tools with existing IT systems to achieve easy exchange of patient data often results in a banging headache, not even mentioning the fact that this medical sector is subject to strict (European) rules and several regulatory authorities. The question is: how to benefit from all advantages promised that should bring healthcare to the next level while also staying in control regarding quality, continuity and safety of healthcare itself?

    Current landscape

    HIM & EHR

    As said, Dutch hospitals are using comprehensive software systems for managing their healthcare, operational, and financial processes. The functionalities of these systems are (broadly) divided in ‘hospital information management’ (HIM) and ‘electronic health records’ (EHR). The first includes the management of patient data, support of the logistics of the care process, and the support of the billing process to health insurers and patients. The latter is used by the hospital to store, retain, and use medical patient data in digital form, and enable access independent of location. Nowadays, both functionalities are either already fully integrated into one comprehensive software system, or hospitals are planning to migrate to such a system in the near future. The main purpose: supporting and improving the cure and care process of a patient.

    Medical applications

    Although current HIM/ EHR systems offer a comprehensive package for the hospital, they are often considered rigid and not really supportive to the continuous and rapid changing environment of healthcare, including the ever-increasing demand of the patient itself to be involved in its own care and cure process. This leaves enough space for other useful third party tools and medical applications.

    Thousands of medical applications are available in app stores to help consumers, patients and doctors. Those who have diabetes for example, can now measure their glucose and transmit the measurement digitally to a database. Doctors and care providers can use ‘telemedicine’ to do physical and psychological diagnosis from a distance, including tele-monitoring of patients’ functions. However, these apps often do not integrate well with the hospital systems.

    Need for flexibility

    This brings us to the first challenge to overcome: enabling an easy interface between existing HIM/ EHR systems and innovative tools and apps. Such an integration requires a high flexibility of the core HIM/ EHR system to enable easy connectivity and data exchange. In many industries, the need for easy inter-system data communication is currently being solved through application programming interfaces (API’s). Consider an API a sort of system socket that you connect to by using a matching plug, but then for data exchange instead of energy exchange. The rise of this new API world order (also sometimes referred to as “Planet of the API’s”) in IT will thus also spread to the healthcare industry.

    Experience learns that it is difficult to achieve an easy integration of third party tools and apps with the core HIM/ EHR systems in place at hospitals. To achieve the desired interoperability, increased attention is needed for assessing the API capabilities and modularity of the core system currently in use or to be implemented soon. The legal side should be considered as well, including the necessary contractual flexibility in this respect as well as necessary roadmap obligations (including associated allocation of funds) to make this happen.

    E-health supervision

    As stated before, the possibilities for (remote) digital care and cure are growing. Any functionality in this respect, whether provided by the core HIM/ EHR system or an app interfacing with the core system, is subject to the magnifying glass of several competent supervisory authorities such as the Dutch Data Protection Authority (Autoriteit Persoonsgegevens) and the Dutch Health Inspectorate (Inspectie voor de Gezondheidszorg). Consequently, when purchasing new solutions, hospitals need to consider the regulatory framework and the issues that are subject to supervision by the authorities. And e-health application manufacturers should not only ensure the safety and quality of the product, but should also focus on privacy and security issues regarding storage and data exchange of digital health records.

    Does the e-health solution comply with legislation?

    In addition to complying with privacy laws, some situations also call for compliance with legislation such as the Medical Devices Act (Wet op de medische hulpmiddelen). For example, there may be need to request and obtain a CE marking (a European product certificate that defines the main civil engineering properties of materials). This is not only an issue for the e-health application manufacturer to consider. In the end, the doctor and hospital determine what type of device, tools or applications are used during treatment. This means that in cases of damages caused by uncertified tools and applications several parties may be liable (the manufacturer, the hospital and/or the treating doctor).

    No complaints do not mean compliance

    This is another example of problems that can arise when e-health manufacturers do not have sufficient knowledge of the applicable legal landscape and the competent authorities. And the fact that an e-health application is used by several hospitals respectively doctors without any complaint or concern or whatsoever does not mean that the application meets all legal requirements. The (wide-spread) use by others does not imply compliance!


    The e-health market is a growing market with great opportunities for new innovative tools and apps, as well as for the healthcare industry itself. At the same time, compliance with relevant legislation and the integration with the existing HIM/EHR systems of hospitals ask for a substantial investment in time and effort, which many vendors and developers cannot afford but the healthcare industry cannot afford to do without. That’s a pity, because these developers often offer innovative solutions that provide the flexibility healthcare institutions are looking for (and need). This sounds like a common interest to achieve common benefits.

    How to bring these worlds closer together? For HIM/EHR system suppliers we would say: open-up your systems and enable easy data exchange using API’s. And do not fight third-party apps and tools that prove to be better than your own functionality: either learn and improve your own functionality, or embrace the added value of third-party solutions. The latter requires a more modular approach to your HIM/ EHR system. And for developers of new apps and tools we would say: challenge HIM/ EHR system suppliers to open up, and incorporate legal compliance in your DNA. Your customers need your solution to be watertight by design in terms of legal compliance. If you do not know how, engage a third-party expert or partner-up with an HIM/ EHR system supplier.

    The common denominator here is close collaboration between the two stakeholders on the supplier side, with understanding (and acceptance) of each other’s interests.  Then one plus one may equal three. This can already be achieved by classic IT distribution relationships with one of the two suppliers aggregating both technologies so that the medical sector can benefit from the best of both worlds. It may also require closer cooperation between parties, for example through mutual investing within the context of brownfield or even greenfield innovation labs. And that may lead to totally different legal topics to address to create a win-win partnership.

    This publication was previously published on Accenture Innovation Awards.