Experiences

HealthTech in 2026: Securing product roadmaps amid new data sovereignty requirements

In 2026, regulatory compliance and data sovereignty are shaping the future of HealthTech. Discover how Novity helps digital health companies accelerate and secure their product roadmaps through a compliance-by-design approach to software engineering.

2026 marks a turning point for the French HealthTech industry. According to the France HealthTech 2026 Panorama, published in January 2026 by France Biotech and EY, digital health now accounts for 40% of the sector, driven by the rise of DeepTech.
‍

But this growing maturity brings new challenges. Compliance is no longer simply a technical requirement to tick off a checklist. It has become a fundamental part of business strategy.
‍

At Novity, we help HealthTech companies turn regulatory constraints into opportunities for sustainable growth. Our Product & Software Engineering approach focuses on building systems where technical compliance directly supports business objectives.
‍

To illustrate this approach, let's examine one of our client projects: supporting the international expansion of a digital pathology leader.
‍

The challenge: Scaling in a highly regulated HealthTech environment

For a post-Series B scale-up looking to expand into new markets across Europe and North America, regulatory complexity should not become a barrier to product delivery.
‍

Our client, a major player in precision medicine, faced three interconnected challenges.

Data sovereignty: With Decree 2026-209, requirements for certified health data hosting providers (Hébergeurs de Données de Santé, or HDS) have become more stringent. Data sovereignty is now a prerequisite for hospital deployments.
Standardising software delivery: Developing bespoke solutions for every customer was no longer sustainable. The company needed a robust core product capable of processing large volumes of medical imaging data.
‍
‍

The Solution: Compliance-by-Design Software Engineering

To support these ambitions, Novity embedded autonomous Product Engineers directly into the client's teams.
‍

The objective went beyond writing code. It was about turning complex algorithms into reliable, production-ready systems capable of delivering clinical value, supported by MLOps practices.
‍

Our collaboration was built around four key pillars :

‍

Data Security and Pseudonymisation

We implemented strict protocols to protect patient information and anonymise shared medical images, an essential requirement for international clinical research.
‍

These measures helped establish a more secure framework for processing and sharing sensitive healthcare data
‍

Quality Assurance and Certification

In healthcare, software quality is critical.
‍

Our QA specialists introduced rigorous testing processes, including web service testing with Postman and test automation, to support the maintenance of ISO 27001 certification.
‍

This approach helped reinforce the reliability and security of the platform as it evolved.
‍

Healthcare System Interoperability
‍

The client's Platform as a Service (PaaS) needed to integrate smoothly into the daily workflows of pathologists, regardless of their geographical location.
‍

Interoperability was therefore essential to ensuring that the platform could operate effectively across different healthcare environments.
‍

A Culture of Collaborative Delivery

Our engineers did more than complete Jira tickets.
‍

They actively participated in backlog refinement and technical estimation sessions, challenging each feature from both a performance and security perspective.
‍

This close integration helped ensure that technical decisions remained aligned with the client's product objectives and regulatory requirements.

‍

The results: Secure growth and international recognition

By combining engineering agility with a rigorous understanding of healthcare requirements, our client was able to turn complex challenges into tangible progress.

‍

An Accelerated Product Roadmap : By standardising functionality using Java and TypeScript, the team strengthened its ability to accommodate customer requirements without compromising the stability of the core platform.
International Recognition: The company was selected for the French Tech 2030 programme and received multiple Best in KLAS awards, internationally recognised distinctions in healthcare technology.
Greater System Maturity: AI evolved from experimentation into an integrated capability that accelerates diagnostic processes while protecting patient data, demonstrating how robust software engineering can support international expansion without compromising security or product quality.

‍

HealthTech in 2026: Towards a New Standard of Trust

As highlighted in Deloitte's 2026 Life Sciences and Health Care Outlook, the healthcare sector is approaching a decisive moment for AI infrastructure.
‍

The industry is moving beyond the limitations of traditional SaaS models, towards longer R&D cycles where risk management plays an increasingly central role.
‍

For Novity, the objective is clear: help ambitious HealthTech companies scale without allowing technical complexity or regulatory requirements to slow their progress.
‍

By integrating experienced engineers who understand the SREN legislation and the challenges of translating technological innovation into clinical practice, we enable our clients to focus on what matters most: advancing treatments and modernising diagnostics on a global scale.

‍
‍

Sources

‍

Frequently asked questions

What is a Product & Software Engineer at Novity, and why is this valuable for HealthTech?

At Novity, a Product & Software Engineer does more than turn specifications into code. They combine strong technical expertise with a deep understanding of product development and business objectives.

In HealthTech, this mindset is particularly important. Every architectural decision and line of code can directly affect the patient experience, data security and regulatory compliance, including GDPR and medical device certification requirements.

Our engineers design software with the end goal in mind: delivering meaningful value throughout the patient care journey.

‍

Why is it so difficult to recruit engineers with both product development and healthcare expertise, and how does Novity address this challenge?

These engineers are particularly hard to find because they need a rare combination of skills: strong technical expertise (Java, TypeScript and cloud architectures) and in-depth knowledge of the healthcare ecosystem, including standards such as HL7/FHIR, DICOM medical imaging and health data hosting requirements.

To address this talent shortage, Novity has established a dedicated team of engineers trained in the specific requirements of digital health. This gives HealthTech scale-ups rapid access to specialised expertise, helping them maintain momentum on their R&D projects without being held back by recruitment challenges.

‍

How do Novity's engineers secure client infrastructure as data sovereignty requirements tighten in 2026?

With the introduction of new regulations such as Decree 2026-209, data sovereignty has become a non-negotiable requirement.

Our engineers assess and adapt client infrastructure to meet the requirements of certified health data hosting environments, including HDS (Hébergement de Données de Santé) and SecNumCloud.

We implement advanced encryption measures, automated data pseudonymisation pipelines at source, and isolated system architectures.

These measures help healthcare software providers deploy their solutions securely and confidently across hospitals and medical laboratories, both in France and internationally.

‍

How does Novity help companies move from bespoke development to a standardised, scalable core product?

This is a common challenge for growing HealthTech companies. To prevent clients from becoming tied to custom development for every hospital or healthcare facility, our engineers apply Clean Code principles and modular software architecture.

By building robust APIs and standardised interoperability layers, we help transform bespoke applications into scalable PaaS or SaaS platforms.

The result is a product that can grow with the business, with reusable code, greater scalability and simpler long-term maintenance.

‍

How does Novity’s collaborative delivery approach support ISO 27001 certification and CE marking?

Certification processes in healthcare are demanding and require rigorous software traceability and documentation.

Because our engineers are fully integrated into client teams and their development workflows — including backlog refinement, code reviews and automated QA — thorough documentation and regression testing become part of everyday software delivery.

This compliance-by-design approach helps avoid last-minute compliance bottlenecks by ensuring that software is auditable from the outset. It also helps streamline certification audits and clinical testing, supporting a more efficient path towards ISO 27001 certification and CE marking.

‍