Blog

Demystifying SaMD Regulation

March 30, 2023
Blog

Demystifying SaMD Regulation

March 30, 2023

Mani Shanmugham

Senior Director Quality & Regulatory at Huma

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If you were to log on to the app store today, hundreds of thousands of products serving a “medical purpose” would appear. In 2020 alone, 90,000 health-related apps were released into the market – an average of 250 per day1. And yet, despite containing patient data and even providing care recommendations, rarely are these applications registered as medical devices. This ambiguity is a potential cause for concern for the entire field of digital healthcare, as emerging tools often lack clinical validation or may be unable to effectively protect patient privacy.

While governing bodies worldwide, like US Food and Drug Administration (FDA), European commission with its Notified Bodies and competent authorities but also ANVISA (Brazil), TGA (Australia), PDMA (Japan) and Health Canada, recognize the gravity of this problem, many of those in charge of medical device regulation come from a traditional, hardware-driven experience. Although they may have a clear understanding of the guidelines required to effectively build blood pressure monitors and ventilators, for example, software as a medical device (SaMD) is an entirely new territory full of unique challenges and opportunities.

With this, it is no surprise that many of our customers come to us with questions and even misconceptions about SaMD regulation. To shed light on these issues, let’s examine some of the most common myths surrounding SaMDs and how our team is pioneering a new path forward for companies entering this emerging environment.

We place our clients’ products on the market as their legal manufacturer. This relationship enables us to take care of all regulatory burdens, allowing our clients to build products that are not only ready-to-use, but compliant.

Mani Shanmugham, Senior Director Quality & Regulatory at Huma

Myth #1: All medical apps or digital health products are equal.

There is a huge variety in medical apps and digital health products, ranging from those that are not regulated at all, and have not submitted any evidence to do so - up to those covering Class I, Class II and beyond with their associated risk classification. Whilst you may not need regulated software for your particular task, such as monitoring activity of patients with diabetes, you may find that the software sounds like it can do everything you need but actually is not allowed to be used as part of a clinical pathway to care for those patients. It’s not always obvious and you need to check it out at the beginning of the process. Also, some software companies will help you create software and put it through approvals, whilst others are already regulated and you can simply start using them straight away without risk or delay.

Myth #2: SaMD regulation is stagnant

Current medical device regulation is struggling to keep up with the iterative nature and fast pace of software development. At Huma, we make it our role to not only educate clients on the SaMD guidelines that exist today but also help them stay ahead of the curve.

To do this, we run programs in parallel to the regulatory process – generating evidence and submitting software updates to notified bodies and regulatory authorities. Our team of developers handle technical file updates, clinical investigations and change notifications during the early design and development of each product while authorities concurrently assess regulatory changes. This process not only saves time but ensures clients are a step ahead – when pending regulation becomes standard practice, their products have already been developed according to these rules.

Myth #3: SaMD regulation is universal.

We know our customers have global ambitions. However, many struggle to expand their offerings as they navigate the complexities of regulations in each new territory they enter. Our team monitors regulations worldwide to ensure all new guidance is integrated into our clients’ products. This international regulatory intelligence helps clients operate and expand their work into any of the top 50 markets across the world. 

Myth #4: SaMD regulation is the responsibility of developers.

Many of our clients assume they hold the sole responsibility to bring their product compliantly onto the market. With other platform companies, this may be true – there are plenty who will simply provide software, parts of the required paperwork, and send developers on their way. Instead, we place our clients’ products on the market as their legal manufacturer. This relationship enables us to take care of all regulatory burdens, allowing our clients to build products that are not only ready-to-use, but compliant.

SaMDs have an important role to play in healthcare delivery. But to realise the full potential of this technology and enable future innovation across the field of digital health, more progress must be made to address its regulation.

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Huma's digital-first health platforms support a network of 27m patients1

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Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Winner of the 2022 Prix Galien award for digital health, widely regarded as 'pharma's Nobel prize'4

Blog

Demystifying SaMD Regulation

March 30, 2023
Blog

Demystifying SaMD Regulation

March 30, 2023

Huma joins digital pioneers to advance health equity in care and research

Chief Executive Officer and Founder, Dan Vahdat, is returning to the annual World Economic Forum’s main conference where he will join a panel discussion devoted to improving care for non-communicable disease and tackling health equity. Accompanied by Chief Financial and Strategy Officer, Ingeborg Oie, Dan is looking forward to connecting with other attendees to explore how Huma’s digital health platform can make healthcare more equitable, and advances proactive, predictive care.

Huma joins digital pioneers to advance health equity in care and research

Date:Wednesday, January 18, 2023
Time:4:15 - 5:15 p.m. CET
Location:Ice Village, Eisbahnstrasse 5, Davos, Switzerland
Dan will join the Digital Health Action Alliance panel at Davos to discuss Turning the Tide in Non-Communicable Disease Care Through Digital Health and Community Connection. Huma has a long history of advancing the care of non-communicable diseases (NCDs) such as heart disease, cancer, diabetes and lung conditions. Huma’s innovative remote patient monitoring platform enables broad patient recruitment, reduces reliance on in-person clinic visits and increases health system efficiency.
*This session is open to registered Annual Meeting 2023 participants and Affiliate badge holders.

Huma is one of the first to sign the Zero Health Gaps Pledge

Huma is one of the first signatories to the Zero Health Gaps Pledge, the World Economic Forum’s Global Health Equity Network’s (GHEN) initiative. Huma supports GHEN’s ambition to build a future without disparities in health or wellbeing outcomes. Huma’s digital platform has been built on a deep clinical knowledge of complex patient needs and how people engage with technology and we are committed to ensuring our technology promotes health equity. We are proud to work with governments, hospital groups, universities, life science and technology companies to bring greater scale and impact and help all people live longer, fuller lives.

Huma at World Economic Forum

Global Innovators and Tech Pioneers
Dec 2022: Huma selected to join 100 innovative companies on a two-year journey as part of the World Economic Forum’s initiatives, activities and events, bringing their cutting-edge insight and fresh thinking to critical global discussions.
Learn more
Working Together, Restoring Trust
May 2022: With the aim to address economic, environmental, political, and social fault-lines exacerbated by the COVID-19 pandemic, Dan Vahdat speaks at WEF annual meeting about the importance of scientific collaboration.
Learn more
Accelerating innovation and breaking new ground
October 2022: Dan joined the WEF Biotech Future Forum 2022 to discuss how start-ups are breaking new ground in biotech and changing the way we interact with the world, but also how the sector can earn trust, scale successfully and spot the brightest innovations.
Learn more
Making connections at Davos
Jan 2019: Dan attended WEF as an unofficial attendee and spoke to CNBC about the importance of meeting in-person to make connections.
Learn more

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Blog

Demystifying SaMD Regulation

March 30, 2023
Media contact
A headshot of Karen Birmingham PhD
Karen Birmingham PhD
Head of PR & Communications
karen.birmingham@huma.com
Blog

Demystifying SaMD Regulation

March 30, 2023
Media contact
A headshot of Karen Birmingham PhD
Karen Birmingham PhD
Head of PR & Communications
karen.birmingham@huma.com

If you were to log on to the app store today, hundreds of thousands of products serving a “medical purpose” would appear. In 2020 alone, 90,000 health-related apps were released into the market – an average of 250 per day1. And yet, despite containing patient data and even providing care recommendations, rarely are these applications registered as medical devices. This ambiguity is a potential cause for concern for the entire field of digital healthcare, as emerging tools often lack clinical validation or may be unable to effectively protect patient privacy.

While governing bodies worldwide, like US Food and Drug Administration (FDA), European commission with its Notified Bodies and competent authorities but also ANVISA (Brazil), TGA (Australia), PDMA (Japan) and Health Canada, recognize the gravity of this problem, many of those in charge of medical device regulation come from a traditional, hardware-driven experience. Although they may have a clear understanding of the guidelines required to effectively build blood pressure monitors and ventilators, for example, software as a medical device (SaMD) is an entirely new territory full of unique challenges and opportunities.

With this, it is no surprise that many of our customers come to us with questions and even misconceptions about SaMD regulation. To shed light on these issues, let’s examine some of the most common myths surrounding SaMDs and how our team is pioneering a new path forward for companies entering this emerging environment.

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About Huma

Huma began its journey in 2011, when the company was founded in London. Since then, Huma has grown to become a global healthcare company, spanning across multiple geographies and operating across four continents.

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