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Decoding Health tech Regulations

Exploring the evolution from wellness apps to regulated medical devices, highlighting the significance of global compliance and security.

Written by:
Daphney Makhetha
Published on:
April 30, 2024

Digital Health Technology Landscape

The digital health technology landscape is heavily skewed towards health and wellness applications. Typical examples include apps to help a person monitor his or her blood pressure or blood glucose levels or provide reminders about taking their daily medications. As long as these products are limited to tracking or informing about their data, they will not be considered medical devices from a regulatory point of view. As such, they are not subject to oversight from regulatory authorities like US FDA or Australia’s Therapeutic Goods Administration. This is a key reason for why there are so many health and wellness applications on the market – all over the globe. It is much easier to develop and bring to market a product that is not under medical device-related regulatory scrutiny than to do so for one that is.

Developers of digital health products need to be aware however that market pressures or other factors may eventually drive initial product designs into new regulatory categories. For example, a health and wellness application that evolves to support clinicians with diagnoses is now driven from its nonregulated status into the highly regulated software as a medical device (SaMD) category. And if client expectations or competitive pressures drive the product even further so that it is diagnosing vs. simply supporting a diagnosis, the product would be pushed into a more highly regulated category (e.g. from Class II to Class III in the US). And which regulatory category these products fall into will vary from market to market across the globe.

Pure Global recommends that digital health product developers lay out the country-by-country medical device-related regulatory requirements that their products will need to comply with. For a health and wellness application this should be easy. Since in most cases regulatory compliance will not be required. It is of course critical to do this on a product’s initial design. But it is as important to anticipate where a product is going (i.e., on its roadmap) and – as much as possible – lay out in the roadmap how the product’s regulatory requirements will change as its capabilities evolve.

Understanding Regulatory Shifts for Digital Health Products

A key element of any digital health-related regulatory roadmap is its compliance with privacy and security expectations. Due to the dramatic increase in security-related threats over the last several years, regulators across the globe have significantly ramped up their scrutiny and expectations around privacy and security. Regulators expect device companies to incorporate security-by-design processes, including risk assessment and threat modeling, over the full expected life cycle of their digital health-based products. In the US, this also includes developing and managing a complete and up-to-date software bill of materials (SBOM), as is now required in the 2023 US Consolidated Appropriations Act.

Most digital health technologies will utilize some form of personal health information (PHI). Managing the privacy of that information is a huge deal from a regulatory point of view. Meeting the global and even state-by-state or region-by-region privacy requirements is at least as daunting as with security, in part because rules can vary significantly from region to region. What privacy requirements a digital health product is expected to meet in the markets it is and will be sold to is a critical component of its global regulatory roadmap.

Support from Pure Global

Pure Global has deep knowledge in global regulatory compliance, including with the unique and complex challenges of digital health-based technologies. Reach out to Pure Global and learn about how we can help you.

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