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The next frontier

Digital health and patient safety

Medical and wearable devices, remote in-vitro diagnostics, and digital therapeutic products - the rapidly evolving world of digital health is bringing more and more devices into patients’ hands. But along with the benefits, there are safety considerations for people and data.

From tradition to technology: patient care evolution

The traditional view of the patient is evolving. The patient is no longer the silent recipient of curated information and care directed by medical professionals. Today patients are entitled to their own data and expected to take more responsibility for their health behaviors and health management. Patients may struggle with technological advances that introduce complexity and potential safety issues. At the same time, healthcare providers have struggled for the last decade to provide digital services comparable to those offered to consumers by other industries. This is a disturbing thought when we consider the significance of the healthcare sector in public and individual health and well-being. The SARS-19 pandemic accelerated the traditionally slow evolution of healthcare delivery into new trajectories and settings, particularly in the digital space.

Lessons from other industries

Unfortunately, too often the devices offered to patients have failed to incorporate the lessons from other consumer industries. Giving medical devices to patients brings two product development disciplines into sharper focus: user experience and design. Manufacturers of digital health devices are familiar with models of care delivery via highly trained clinicians. In those cases, the risks and human factors aspects are minimized because devices are administered by “experts”. Relatively simple physiological measurement devices and diagnostic tests have been on the market for decades. However, the increasing technological advances reflected in modern devices drive a steep learning curve to move from the expert-directed model towards a patient-centric one. In this new model, patient risk and human factors are vital components of a successful patient-administered device. Notably, the medical device industry lags the consumer device industry in design terms. Pioneers like Apple simplified technology usage instructions through streamlined user interfaces with recognizable icons, natural language, and intuitive design.

Digital disruption and new frontiers in healthcare

For patients, medics and researchers, digital devices offer multiple benefits. They allow patients and health professionals to track early warning signs and symptoms without travelling to, or waiting for, an appointment. For researchers these devices can help retain participants in clinical studies by reducing the burden on patients. Data can be recorded easily and remotely. Automation and reminders mean that patients don’t need to rely on memory to know when and what to record. Digital devices may be more cost effective in the long-term, allowing medics and patients to be more proactive with treatment and lifestyle adjustments. While there are challenges with design, data security and user experience these are not insurmountable. When the device industry overcomes them, patients will realise the true value of digital health in the home and  other non-typical healthcare environments. 

Digital safety was described by Flott et al. (2021) as the next frontier for patient safety.1 At ICON we put risk management, human factors, and cybersecurity front and centre as we work with our customers to bring their devices to market.

Learn more about digital disruption.

1 Flott K, Maguire J, Phillips N. Digital safety: the next frontier for patient safety. Future Health J. 2021 Nov;8(3):e598-e601. doi: 10.7861/fhj.2021-0152.

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