Technology
A new e-health application is rarely, if ever, a ready-made solution. It takes extensive research to be sure that it is the right solution for the intended task. New applications often seem attractive and promising until all aspects of the development process have been taken into consideration.
Due diligence requirements.
Before investing in a technology, it is important to ensure that the company selling the technology is legal and creditworthy, that the technology complies with the required legal standards, that personal data is handled with care, and that all associated risks have been considered. There are numerous sources available on these due diligence requirements that may be useful for your project, such as the following:
Ploum.nl [What about privacy in e-health applications?]
Information about privacy considerations in eHealth applications.
Gezondheidsraad.nl [Health apps and wearables]
Detailed information about ethical issues surrounding health apps and wearables
igj.nl [Assessment framework for the use of e-health by healthcare providers]
Assessment framework of the Health and Youth Care Inspectorate (Ministry of Health, Welfare and Sport) for the use of eHealth by healthcare providers.
igj.nl [Safe use of eHealth]
Safe use of eHealth by the Health and Youth Care Inspectorate (Ministry of Health, Welfare and Sport).
Rijksoverheid.nl [When does software fall under the new European rules for medical devices?]
Description of when software is classified under the new European rules for medical devices, by the Dutch government.
Ncsc.nl [Security guidelines for mobile devices]
Two-part document on security guidelines for mobile devices drawn up by the National Cyber Security Centre (Ministry of Justice and Security)
Inform yourself about the technology and assess its quality and implications.
If you are not developing the technology yourself, familiarize yourself with all relevant aspects of it. You may want to ask an expert to help you think it through. Look at the technology, try it out, and take a walk through a hypothetical usage scenario. Will this technology really help you achieve what you want to achieve? Could another technology (perhaps one that has already been tried and tested) achieve the same thing with less effort?
Fda.gov [medical device databases]
Database of all medical devices currently on the market, updated regularly.
Ec.europa.eu [eudamed]
European database of all medical devices, certificates and manufacturers.
Investigate the origin of the technology and potential challenges
Ideally, the components of your chosen technology, such as coding platforms or devices, should be easily accessible or purchasable. Avoid long lead times or unreliable suppliers. Preferably, the technology should not depend on a single supplier, device, or programming language, allowing you to switch to alternatives if needed. Components should be thoroughly tested for reliability. Investigate potential conflicts of interest or intellectual property claims before starting the project. Clarify who will finance the technology, the expected costs, and which expenses (setup, maintenance, updates, etc.) will need to be covered.
Identify the key areas where technical complexity will impact success and address these
Look for missing or unknown data and dependencies as soon as possible and develop a plan to deal with them, including alternatives. Avoid or reduce unnecessary technical integration, because integrating systems makes everything more complex. However, some forms of technical integration can make it easier for a healthcare provider to use the technology. This applies, for example, to working with software from the electronic patient record.
Assess how the technology will disrupt the system.
Identify potential disruptions and take measures to minimize them as much as possible. Can you adapt the technology? Can you opt for other systems or processes? What measures can you take (e.g. a small-scale pilot project parallel to the existing service, on-the-job training, helpdesk) until the systems and processes are ready for the new technology? See also domain 5: organization.
Zorginstituutnederland.nl [Implementation of the guideline ‘New interventions in clinical practice’]
Implementation of the guideline ‘New interventions in clinical practice’.
Zorginstituutnederland.nl [Implementation of the guideline ‘New interventions in clinical practice’]
Implementation of the guideline ‘New interventions in clinical practice’.
Demedischspecialist.nl [New Interventions in Clinical Practice]
Guidelines for new interventions in clinical practice.