Navigating the compliance pathway for healthcare products can be an uphill journey, especially when the path involves meeting the rigorous standards of the NHS in the UK. In this blog, we delve into a topic that is often shrouded in complexity and misconceptions; the NHS Digital Technology Assessment Criteria (DTAC) and compliance.
The Essence of DTAC: More Than a ‘One-Off’ Task
The NHS DTAC consists of 5 core components; Data Protection, Clinical Safety, Technical Security, Interoperability, and Usability and Accessibility. Despite the misconception, DTAC is not a tick box exercise. It’s a continuous process with a prime focus on maintaining the highest standards in every aspect of a digital health technology product. For innovators, the compliance journey doesn’t end after meeting these standards just once; it requires an ongoing commitment to quality and safety through the product lifetime journey.
Not Just a ‘Tech’ Checklist: Compliance is not only about the technical prowess of a digital solution. It means ensuring that the product is safe, secure and beneficial to both healthcare professionals and patients. The NHS DTAC ensures that digital health suppliers are held to account for upholding the integrity and safety of their products consistently.
Regulated vs. Non-Regulated Products: Whether a product is regulated, like Software as a Medical Device, or non-regulated, it has its distinct pathway towards compliance. Both pathways require a deep understanding and adherence to the various standards and laws that are applicable to them.
The Key To A Smooth Compliance Journey
- Building a Robust Information Governance Framework: It goes beyond GDPR and necessitates developing a structure that governs how data is handled, used, and secured within your organisation. Establishing an Information Governance function early on can shield you from future challenges.
- Addressing Clinical Safety from Day One: By abiding by standards like DCB0129 and ensuring that a competent Clinical Safety Officer (CSO) is in place, you can assure that clinical safety is woven into the fabric of your product development and lifecycle from the start.
- Tech Security Can’t Be an Afterthought: Ensuring the secure handling and storage of sensitive patient data and other critical information is paramount. A strong technical security protocol, aligned with Cyber Essentials and informed by regular external Penetration tests, builds credibility and trust.
The Invisible Hurdles
Conforming to Ever-Evolving Standards: Maintaining up-to-date compliance is essential for your product’s position in the healthcare industry. Businesses must monitor and address health tech product regulations to avoid pitfalls during the tendering process, as many have and continue to be, faltered by not meeting DTAC expectations.
Balancing Usability and Compliance: Building a product that is both fully compliant and user-friendly can feel like a long walk on a tightrope. Striking the right balance without compromising on either end is crucial for the product’s success and acceptance in the market.
Two Targets, One Arrow
For health tech organisations that want to scale globally, it’s worth considering compliance with the International Standards Organisation (ISO) in line with the DTAC from the outset. Not only could this save you money in the long run, but also the pain of realigning your product and its supporting compliance documentation with ISO guidelines in the future.
Compliance with ISO standards like ISO 27001, ISO 9001, ISO 14971, and ISO 13485 significantly aids in meeting NHS DTAC compliance obligations, while also setting up your business for compliance success internationally. Whilst ISO 27001 and ISO 14971 act as no supplement for the requirements set out in the DTAC framework, if you’re a business that has already adopted and implemented these standards, satisfying the DTAC is a much simpler exercise.
Want to learn more about how the ISO standards could pave the way for DTAC compliance and global success in health tech for your business? Book a no-obligation discovery call with one of our experts.
The Road Ahead
Embarking on the NHS DTAC compliance journey requires a blend of meticulous planning, continual adherence to standards, and a thorough understanding of the regulatory landscape. But, it’s also worth considering DTAC in line with your organisation’s plans for growth, regardless of whether that’s here in the UK’s NHS, or further overseas. Regulation and compliance in health tech is not a one-time sprint but a marathon that demands sustained effort and a collective approach to quality.
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