Care providers must ensure the quality and safety of the care they provide, including digital healthcare (or eHealth). This is subject to supervision by the Health and Youth Care Inspectorate (IGJ). The IGJ’s supervision covers areas such as the organisation and implementation of eHealth, patient involvement, information exchange and information security. The focus areas of the IGJ are described in the assessment framework entitled 'The Use of eHealth by care providers'. The Healthcare Quality, Complaints and Dispute Act (Wkkgz), in conjunction with other laws and regulations, is the legal framework for this supervision.
Supervision of eHealth at care providers
Digital innovations can be found in all healthcare sectors. Care providers are becoming increasingly dependent on a range of eHealth applications. For example, digital patient and client dossiers and digital prescription systems are now firmly established in healthcare. The digital exchange of information among different care providers has become very important for networked care. Video calls and home monitoring tools are creating more and more opportunities for remote care arrangements.
One of the risks in the use of eHealth, therefore, is its dependence on technology. For example, an ICT outage (English) will immediately affect the care. A study commissioned by the Netherlands Association for Clinical Physics showed that ICT-related issues come in fourth place in a nationwide Safe Incident Reporting (VIM) inventory. If crucial information is not available, or not available in full, this may have harmful consequences for patients.
Laws and regulations and field standards for supervision
Legislation and standards in the field of ICT and care are in a permanent state of development. For example, in addition to the The Healthcare Quality, Complaints and Dispute Act (Wkkgz) (English) there is a Processing of Personal Data in Healthcare (Additional Provisions) Act. New legislation is currently being drafted that will make digital data exchange the standard for the healthcare sector (Healthcare Sector (Electronic Data Exchange) Act). The legislator has designated the IGJ as the supervisory authority.
The assessment framework entitled The use of eHealth by care providers (English) is derived from a large number of laws, regulations and other standards, including the following:
- Healthcare Quality, Complaints and Disputes Act (Wkkgz)- English
- Wkkgz Implementation Decree
- Processing of Personal Data in Healthcare (Additional Provisions) Act
- Healthcare Governance Code
- Good Governance Framework
- Quality Framework for Nursing-home Care
- Guide to the division of responsibilities for collaboration in healthcare
- Performance indicators in the quality assurance of medical systems
- Quality Standard for the Transfer of Medical Data within the Chain
- KNMG Guideline for Electronic Prescribing
- Medical Technology Covenant
- Guideline for New Interventions in Clinical Practice
- Guide to Home Automation for Patient Supervision Purposes
- NEN 7510 Medical informatics – Information security in the healthcare sector
- NEN 7512 – Basis for trust for exchange of data
- NEN 8009 – Safety management system for hospitals and organisations that deliver hospital care
- NEN 8028 Medical informatics – Quality criteria for services and systems for telemedicine (English)
- NEN-EN-ISO 22301 Social security – Business continuity management systems (English)
What does the IGJ focus on?
The IGJ has a permanent focus on the theme of eHealth in care institutions. In its supervision, the IGJ relies on The use of eHealth by care providers, an assessment framework (English) which specifies the IGJ's focus areas during audits of care providers, for instance. The reports of the audits of care providers can be found at IGJ Supervision Documents.
These are the focus themes for supervision:
eHealth potentially has far-reaching consequences for the organisation of healthcare. There is a need for clear agreements, therefore, about tasks, responsibilities and decision-making processes.
eHealth products and services tend to be quite complex. Their use involves a wide variety of interested parties. This calls for a balanced process for the introduction of eHealth that ensures attention for wishes and requirements, risks, training, testing and maintenance.
Many eHealth applications are intended to help patients. However, they will only work if patients are willing and indeed capable of using the new services. This is a matter that demands attention. High-quality information, support and after-care for patients are very important in this context.
eHealth creates opportunities for different kinds of collaboration, among care providers (e.g. for transfer purposes) and between the care provider and the patient. This calls for clear agreements among care providers, and between care providers and their ICT suppliers. One important type of data exchange is the exchange of medication data.
Electronic Prescription System (EVS)
According to the IGJ, digital prescription techniques are important as they contribute to medication safety. An EVS can assist care providers in taking difficult decisions about medication. In addition, an EVS can help prevent errors caused by illegible prescriptions. For more information, see: the supervision of electronic prescription and medication safety.
The growing dependence on technology brings new risks, and organisations need to be prepared for those risks. This includes measures to ensure effective protection of their data, and measures to deal with temporary disruptions in the availability of data during a power failure.
Information security
Care providers are responsible for high-quality information security, in accordance with the statutory NEN 7510 standard. Their compliance has to be regularly verified by an independent expert. The IGJ may require insight into such verifications during an eHealth-related audit. In such a case, the care provider must be able to show proof of a recent independent assessment of their information security systems. For more information, watch the Video college on Information Security: Health and Youth Care Inspectorate (3:05 min.)
Supervision in progress
eHealth is developing all the time, and supervisory arrangements are developing with it. This resulted in an assessment framework for home monitoring, for example.
The IGJ performs inspections, collects information and learns from the supervision it performs. It shares that knowledge by publishing fact sheets. One example is Extra attention needed for ICT in youth care, a fact sheet in which the IGJ describes the results of a study into ICT and eHealth among providers of youth care services.
In the healthcare sector, it is becoming increasingly important to also focus on partnerships of care providers. Finally, the IGJ also assesses the structure of the supervision of small care providers, for instance in primary healthcare: see the eHealth fact sheet.
The IGJ can also perform inspections during unexpected developments, as it did during the coronavirus crisis, for example; see the fact sheet entitled Home monitoring of COVID-19 patients.