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.
HealthTech in 2026: Securing product roadmaps amid new data sovereignty requirements
Sonia Martin
Sonia Martin
CMO Novity
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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.
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But this growth also brings new demands. Compliance is no longer just a technical box to tick. It is now a core part of business strategy.
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At Novity, we help HealthTech companies turn regulatory limits into growth opportunities. Our Product & Software Engineering approach focuses on systems where technical compliance supports business goals.
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To show this approach, let's look at one client project: helping a digital pathology leader grow across borders


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The challenge: Scaling in a highly regulated HealthTech environment

For a post-Series B scale-up expanding into Europe and North America, regulatory complexity should not block product delivery.
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Our client, a major player in precision medicine, faced two linked challenges.

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  • Data sovereignty: With Decree 2026-209, the rules for certified health data hosting providers (Hébergeurs de Données de Santé, or HDS) became stricter. Data sovereignty is now required for hospital deployments.
  • Standardising software delivery: Building bespoke solutions for each customer was no longer sustainable. The company needed a strong core product that could process large volumes of medical imaging data.
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The solution: Compliance-by-Design software engineering

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

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The goal was not just to write code. It was to turn complex algorithms into reliable, production-ready systems that deliver clinical value, with support from MLOps practices.
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Our collaboration was built around four key pillars :

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  • Data Security and Data Marketing

We put strict rules in place to protect patient data and mask shared medical images. This is essential for cross-border clinical research.

These steps helped create a safer framework for storing and sharing sensitive healthcare data.


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  • Quality Assurance and Certification

In healthcare, software quality is critical.

Our QA specialists added strong testing processes, including web service testing with Postman and test automation, to help maintain ISO 27001 certification.

This helped improve the platform's reliability and security as it evolved.
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  • System Compatibility

The client's Platform as a Service (PaaS) had to fit into the daily workflows of pathologists, no matter where they were based.

Compatibility was essential so the platform could work across different healthcare settings.

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  • A Culture of Collaborative Delivery

Our engineers did more than close Jira tickets.

They joined backlog refinement and technical estimation sessions, challenging each feature from both a performance and security angle.

This close work kept technical decisions aligned with the client's product goals and regulatory compliance requirements.

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The results: Secure growth and international recognition

By combining engineering agility with a strong grasp of healthcare needs, our client turned complex problems into real progress.
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  • A Faster Product Roadmap: By standardising features with Java and TypeScript, the team strengthened its ability to meet customer needs without hurting core platform stability.
  • International Recognition: The company was selected for the French Tech 2030 programme and received multiple Best in KLAS awards, globally recognised honours in healthcare technology.
  • Greater System Maturity: AI moved from testing into an integrated feature that speeds diagnosis while protecting patient data. This shows how solid software engineering can support international growth without sacrificing security or product quality.

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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 reaching a turning point for AI infrastructure.

The industry is moving beyond the limits of traditional SaaS models toward longer R&D cycles, where risk management matters more.

For Novity, the goal is clear: help ambitious HealthTech companies scale without letting technical complexity or regulatory compliance slow them down.


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By bringing in experienced engineers who understand the SREN law and the challenge of turning innovation into clinical practice, we help our clients focus on what matters most: advancing treatments and modernising diagnostics on a global scale.
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Sources

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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.

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

HealthTech engineers need a rare mix of technical skills in Java, TypeScript and cloud architecture, alongside expertise in healthcare standards such as HL7, FHIR and DICOM, and health data hosting requirements.

Novity’s dedicated digital health engineering team gives HealthTech scale-ups fast access to specialist expertise, helping them maintain R&D momentum and reduce recruitment delays.

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

With regulations such as Decree 2026-209, data sovereignty is essential for HealthTech companies.

Novity adapts client infrastructure to meet HDS (Hébergement de Doand SecNumCloud requirements, implementing encryption, automated data pseudonymisation and isolated system architectures.

These measures help healthcare software providers deploy secure solutions across hospitals and medical laboratories in France and internationally.

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

To help HealthTech companies scale without bespoke development for every healthcare site, Novity applies Clean Code principles and modular architecture.

We build robust APIs and standardised interoperability layers to turn custom applications into scalable PaaS or SaaS platforms.

The result is reusable code, easier maintenance and sustainable growth.

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

Healthcare certification requires rigorous software traceability and documentation.

Novity’s engineers integrate into client teams, following established workflows for backlog refinement, code reviews and automated QA. This makes documentation and regression testing part of daily development.

Our compliance-by-design approach reduces late-stage delays, simplifies audits and clinical testing, and supports the path to ISO 27001 certification and CE marking.

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