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 what documentation exists for the technology’s performance.
At TRL 5, results are available from testing an integrated system solution under simulated operating conditions in a laboratory. From there, the technology must be tested in real-life use situations in the field. During this product development process, moral and ethical challenges related to the technology should be assessed before it is tested on humans.
Moral and Ethical Challenges in the Development of Health Technology May Include:
- Autonomy, integrity, and dignity
- Confidentiality and the right to privacy
- Time 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 rationality at the expense of care rationality (with focus on suffering, despair, distress, hope, and coping)
Certification
A key standard for testing new health technology on humans 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 not permitted to test prototypes developed in non-calibrated laboratories. This is considered responsible research in accordance with the Medical Devices Act. If the laboratory is not calibrated, interpreting the results is ethically unjustifiable. The requirement for calibrated laboratories applies from TRL level 6 and upwards.
Resources
- https://www.iso.org/ISO-IEC-17025-testing-and-calibration-laboratories.html
- [Technology Readiness Level (TRL)]
- [Ethical challenges in welfare technology]
- [CoTech: 28 million NOK for a major project at USN]