Regulate digital health to accelerate growth in global health marketRegulate digital health to accelerate growth in global health market

In the fast-moving world of digital health, regulation is often seen as a blocker to advancement, but the most successful companies treat it as a blueprint for growth. By building compliance into product development from day one, startups can avoid costly delays, earn trust faster, and strengthen their market position.

This “compliance by design” approach means privacy, safety, and quality standards are baked into the product and not just added at the last minute. Instead of just avoiding penalties, early compliance helps startups sell more confidently, grow faster, and unlock partnerships with hospitals, insurers, and investors who expect rigorous standards.

Frameworks that make scaling easier

Innovators don’t need to reinvent the wheel trusted global frameworks can simplify compliance without slowing progress and one way to do this is to leverage proven frameworks.

Standards such ISO 13485 which is a globally recognised quality management standard for medical devices, ensure a company’s processes meet high safety and efficacy requirements.

Likewise, ISO 27001 certification (for information security) demonstrates robust data protection practices, aligning a health-tech company with healthcare privacy laws like HIPAA in the US and GDPR in Europe.

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For example, Germany’s DiGA scheme requires ISO 27001 for digital health apps to qualify for reimbursement. By using these frameworks early, companies can scale with confidence, knowing their systems are secure, trusted, and audit ready.

Aligning innovation with regulation

Far from limiting innovation, regulation can fuel it. Designing products to meet regulatory standards creates structure often resulting in better, safer technology. This process of building products to meet regulatory requirements forces a discipline that often improves the product itself.

In a crowded market, having a CE mark or FDA clearance signals credibility, helping companies stand out to patients, partners, and investors.

Companies that anticipate regulatory trends can position themselves as trusted pioneers. Engaging compliance experts early ensures that innovation happens within ethical, legal boundaries.

Navigating the global regulatory maze

Digital health is a global market, with diverse jurisdictional rules. Apps must comply with HIPAA in the U.S. and GDPR in the EU
. The FDA now regulates many software-based treatments as Software as a Medical Device (SaMD). In the EU, MDR 2017/745 sets a high bar for CE marking, while the UK’s MHRA remains the national regulator. Companies need a multi-jurisdictional compliance strategy, often by designing to the most stringent regulatory standard.

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Ada Health’s AI-powered symptom checker is a standout example of compliance-driven innovation.

From the outset, the company adopted an ISO 13485-certified quality management system, enabling it to meet the stringent requirements of the EU’s Medical Device Regulation (MDR 2017/745).

As a result, Ada became one of the first digital health tools to achieve Class IIa certification under the MDR. This early commitment to regulatory excellence not only ensured product safety but it also established Ada as a trusted partner for healthcare providers and insurers across Europe. The company’s proactive alignment with EU standards has since supported its international expansion and built a reputation for clinical credibility.

On the other hand, the opposite was the case for UK’s Babylon Health and its meteoric rise in the digital health space was not without turbulence.

Its AI-driven triage chatbot, initially presented as a diagnostic tool, attracted attention from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The regulator ruled that the technology qualified as a medical device under EU law and therefore required CE marking and formal safety validation. Babylon’s initial approach which was rapid iteration without sufficient regulatory oversight led to public scrutiny and questions about patient safety.

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And their costly lesson for innovation was that speed must not come at the expense of compliance, particularly in healthcare, where trust and safety are paramount.

And finally, what happens when compliance is part of innovation? Teladoc Health, a pioneer in virtual care delivery, recognised early on that robust data protection would be key to scaling its platform globally. To this end, the company secured HITRUST CSF certification — a gold standard for healthcare cybersecurity that aligns with HIPAA compliance in the United States.

This rigorous certification process included independent audits of security controls and privacy protocols, offering strong assurance to enterprise clients such as health systems, insurers, and large employers. Teladoc’s investment in compliance has helped the company operate confidently in over 175 countries, cementing its reputation as a secure and dependable telehealth provider.

It goes without saying, that in digital health, regulation and innovation can reinforce each other. Companies that embed compliance into their innovation strategy stand to grow faster, safer, and with more credibility.

The future belongs to those who view regulation not as red tape but as the blueprint for sustainable innovation.

References available on request.