Smart medical devices and at-home care have gathered significant momentum in recent years, as they allow healthcare providers to remotely monitor patients’ and provide higher quality. Integrating these devices into healthcare systems is not without drawbacks, with patient trust and regulatory compliance being high on the agenda. Many technology components make up smart medical devices.
Embedding security, privacy, and ethics across the entire life cycle of the device, from ideation to end of use, presents multiple challenges:
1.A lack of fit-for-purpose enterprise-wide privacy, security or AI framework that can be implemented in the development process.
2.Organizational silos preventing stakeholders collaborating to deliver trusted outcomes.
3.Lack of understanding of what needs to be done across the life cycle of the device.
what can be done in practice:
1.Co-create and embed a trust by design framework.
2.Set up integrated teams that break down organizational silos.
3.Use well-designed processes and GRC tooling.
4.Leverage key stages of the product life cycle.
These will need to extend to and explain privacy and ethical considerations as it will soon become an operating imperative for smart medical device manufacturers to overtly demonstrate compliance and trust to patients, healthcare providers, and governments.