- According to the Norwegian Board of Technology, care technology refers to “technologies that can assist in performing tasks currently carried out partly or entirely by public care services.”
- Welfare technology is also defined as technology that can support users in their daily lives.
- Health technology, on the other hand, is more narrowly focused on the prevention, diagnosis, treatment, and follow-up of human health, and is more specific than welfare technology.
When new technology is to be developed and commercialized, all safety aspects must be tested and verified in real-life use situations. It is also required that the technical equipment has been developed in a laboratory with calibrated equipment before it is tested on humans.
Technology Readiness Level (TRL)
Technology maturity is measured using the TRL scale, from TRL level 1 to 9. This scale indicates how far the development process has progressed and the documentation that exists concerning the technology’s performance. Starting with TRL 5, results are available when an integrated system solution has been tested under simulated operating conditions in a laboratory. After this point, the technology must be tested in real-life situations in the field. During the product development process, moral and ethical challenges related to the technology should be assessed before being used on people.
Moral and Ethical Challenges in the Development of Health Technology May Include:
- Autonomy, integrity, and dignity
- Confidentiality and the right to privacy
- Time needed for human contact and relationships
- New stakeholder groups: relatives, technology providers, maintenance personnel
- New responsibilities for healthcare personnel and relatives
- Conflicts of interest: Does the technology serve patients/users, healthcare professionals, service providers, or the industry?
- Promotion of instrumental approaches to care rather than on suffering, despair, distress, hope, and coping
Certification
A key standard for testing new health technology on human beings is that the technical equipment must have been developed in a laboratory certified according to the ISO 17025 standard. All laboratory equipment must be calibrated to ensure that the results obtained are accurate and reliable.
It is a requirement that prototypes be developed in calibrated laboratories. This is considered responsible research and is in accordance with the Medical Devices Act. If the laboratory is not calibrated, results cannot be ethically justifiable. The requirement for calibrated laboratories applies from TRL level 6 and upwards.