Technology Continues to Transform Healthcare and the Regulatory World

Introduction:
Digital health solutions are advancing rapidly in the field of diagnostics, emergency response, hospital management. As the goal of individuals shifts more towards self care and de-stressing, technology is changing the way people take care of themselves and the way healthcare providers are managing work stress.

How is technology evolving healthcare?
According to a recent survey released by the Canadian Institute For Health Information (CIHI)(1), technology is helping improve the Canadian health care system. 93% of Canadian primary care physicians use electronic medical records EMRs in their practice. By reducing the administrative burden, healthcare providers can work in a cross functional team to provide better and quicker solutions to their patients. Wearable technology (2) is shaping the health of end consumers daily. Since its inception in the 1960s, it has evolved as portable devices that can act as a reminder for self healing. With time, people are shifting their health focus from curative to preventive. Wearable devices have been able to connect the dots of timely access to physicians and real time data of patients.

With increasing number of healthcare IT companies, the number of software products cleared by the regulatory bodies has also increased. With over 1000 Software as a Medical Device (SaMD) approved by Health Canada, over 500 Artificial Intelligence and Machine Learning (AI/ML) enabled (3) FDA approved medical devices, the enormous contribution of technology in healthcare is hard to ignore. The last few years have seen a tremendous increase in applicable guidance and regulatory requirements when it comes to SaMDs or AI/ML enabled medical devices globally. Recently, Health Canada released a draft guidance on pre-market guidance on machine learning-enabled medical devices (MLMD). It aims to introduce the concept of a predetermined change control plan for the ML system of an MLMD (4).

Conclusion:
Healthcare, being the fastest growing industry in the world needs rapid advancements to provide timely and affordable care to all. Technology is helping with solutions to ease the ever-growing burden on the health care system globally. However, with increasing challenges of security, data protection, patient safety, clinical safety; manufacturers, and regulators are ensuring that these challenges are met, and healthcare keeps evolving.

Author: Himanshi Singla

References:

1. Canadian Institute for Health Information. International survey results reveal challenges experienced by family doctors | CIHI

2. Lu L, Zhang J, Xie Y, Gao F, Xu S, Wu X, Ye Z. Wearable Health Devices in Health Care: Narrative Systematic Review. JMIR Mhealth Uhealth. 2020 Nov 9;8(11):e18907. doi: 10.2196/18907. PMID: 33164904; PMCID: PMC7683248.

3. Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices | FDA

4.  Draft guidance: Pre-market guidance for machine learning-enabled medical devices. Draft guidance: Pre-market guidance for machine learning-enabled medical devices - Canada.ca