H.Core: AI Platform
The AI platform behind every product we build. And every product we build with you.
H.Core is Newel Health's proprietary AI development platform, integrating regulatory compliance, behavioural science, machine learning, and real-world clinical data into a single certified foundation for building SaMDs. Faster. Safer. Already proven in the clinic.
The problem H.Core solves
Most digital health projects don't fail because of bad ideas. They fail because of what happens after the idea.
Building a Software as a Medical Device is not like building software. It is not like building a medical device either. It is both, simultaneously, under a framework that demands traceability, risk management, clinical validation, cybersecurity controls, and post-market surveillance at every stage of the product lifecycle.
Most organisations discover this too late. A proof of concept becomes a prototype. The prototype shows promise. And then the real work begins: the documentation, the validation, the regulatory submissions, and the timeline triples, the budget doubles, and the product that was supposed to be in market in 18 months is still in development three years later.
This is not a rare outcome. It is the default outcome for teams that try to build regulatory compliance into software that was never designed for it.
H.Core was built to make it the exception, not the rule.
3×
typical timeline increase when compliance is retrofitted late
2×
average budget overrun for SaMD projects without pre-certified infrastructure
18 mo
how long teams expect to reach market before the regulatory work starts
3 yrs
how long it actually takes without the right foundation in place
What H.Core is
Not a shortcut. A head start, built on years of certified manufacturing.
H.Core is the platform that Newel Health uses to build every one of its own products and to build with partners. It is not a template. It is not a low-code tool. It is a mature, ISO-certified software framework that has already served as the foundational architecture for multiple CE MDR Class IIa medical devices.
Every component of H.Core has been built, documented, and validated under IEC 62304. Its risk management approach follows ISO 14971. Its data handling is 21 CFR Part 11 and GxP compliant. Its privacy architecture is GDPR and HIPAA aligned by design, not by retrofit.
When you build on H.Core, you are not starting from zero. You are starting from a foundation that has already passed regulatory scrutiny, and inheriting the compliance evidence and clinical AI capability that came with it.
At its core, H.Core brings together three layers
A behavioral science engine
Continuously informed by consented real-world data, the behavioral layer is what makes Newel's products work for patients over time, not just in clinical trials. It embeds evidence-based behavioral change mechanisms into daily patient interactions, driving the engagement and adherence that clinical outcomes depend on.
An AI and machine learning layer
Trains, validates, and monitors clinical models against real-world patient data, continuously, not just at the point of development. As products accumulate evidence from deployment, the models improve. Clinical use becomes a data source. Data becomes better AI. Better AI becomes better outcomes. This feedback loop is what separates AI built for regulated medicine from AI built for demos.
A pre-qualified component library
A growing set of validated software modules including authentication, consent management, medication reminders, adherence tracking, and secure data handling that new products can inherit directly. Each module is already documented under IEC 62304 SDLC, meaning the compliance work has been done once and can be applied many times.
What this means in practice
Less time on compliance infrastructure.
More time on clinical AI that actually works.
For pharma and medtech partners building a SaMD, the practical value of H.Core is straightforward: it eliminates the most time-consuming and unpredictable part of the development process, specifically the regulatory foundation, so that the team can focus on what is clinically differentiated about their specific product. Including the AI that drives it.
You get to market faster
The core architecture, documentation, and validation work has already been done. New applications built on H.Core inherit compliance evidence rather than generating it from scratch.
You de-risk certification
The platform's MDR heritage is proven. The risk of discovering a fundamental compliance gap at the point of regulatory submission, the failure mode that kills timelines, is dramatically reduced.
You maintain flexibility
H.Core is deployment-agnostic. It runs on any major cloud infrastructure or on-premise, avoids vendor lock-in, and can satisfy local data residency requirements across markets.
You stay secure
The platform operates a continuous vulnerability scanning and patch management cycle. Cybersecurity compliance is not a point-in-time audit. It is a permanent operational state.
Your compliance compounds
When the platform is updated for a new cybersecurity standard, a regulatory change, or a data protection requirement, every product built on it benefits at once.
Your AI gets smarter over time
H.Core aggregates anonymised real-world data across deployments into a centralised, compliant analytics layer. Every patient interaction becomes signal. Every product deployment strengthens the clinical models underneath. AI built on H.Core is not static. It learns.
Proven in the clinic
Built in theory. Validated in practice.
H.Core is not a platform built in anticipation of products. It is the platform that already powers Newel's certified product portfolio, including two CE MDR Class IIa certified devices, and the clinical study infrastructure behind the Soturi Parkinson's program.
Every claim we make about its compliance properties is backed by products that have been through regulatory submission, post-market surveillance, and real-world clinical deployment. That is the difference between a framework and a proven foundation.
2
CE MDR Class IIa certified products built on H.Core
IEC 62304
Every component documented and validated
ISO 14971
Risk management approach
GxP
21 CFR Part 11 compliant data handling
Architecture in action
One data point. Every layer. Follow it through.
From wearable sync to clinical alert — select any node to see what H.Core does at that stage.
The user interacts with the digital product — syncing a wearable, submitting a measurement, or filling a symptom diary. Before any data enters the platform, identity is verified. A step-up MFA challenge fires when anomalous signals are detected.
Ready to build on a foundation that's already been certified?
Whether you are at the discovery stage or approaching regulatory submission, H.Core can accelerate your path to a certified, deployable SaMD. Let's talk about what you are building and where we can help.