ISO 27001 in Healthcare: Why Certification Matters for Digital Health Providers

In digital health, trust is everything. We have already established that in one of our previous blog posts.  Patients, insurers, and healthcare organizations depend on platforms that handle sensitive health data with integrity, security, and transparency. One of the strongest signals of that commitment is ISO 27001 certification, the globally recognized standard for information security management. For companies like Thryve, achieving ISO 27001 goes beyond compliance; it represents a foundation for innovation built on trust.

This certification gives partners and clients confidence that every data transaction, whether it involves wearable devices or health analytics, meets top international standards for privacy, confidentiality, and security. So, what does ISO 27001 mean for digital health providers, and why is it so important today?

What ISO 27001 Certification Actually Means

According to the International Organization for Standardization, 27001 is an internationally recognized framework for establishing, implementing, maintaining, and continually improving an Information Security Management System (ISMS). It defines how an organization manages sensitive data, covering everything from risk management and data protection to employee access controls and incident response.

To become certified, organizations must undergo rigorous external audits by accredited bodies that verify every aspect of their security posture. This includes documenting processes, testing controls, and demonstrating ongoing compliance. It is important to note that ISO 27001 is not a one-time achievement; it requires continuous monitoring, improvement, and renewal.

For digital health companies, this certification means every piece of infrastructure and every employee follows a verified process that ensures data confidentiality, integrity, and availability.

Why It Matters for Digital Health Providers

In healthcare, digital data is the new foundation, which only drives the stakes higher. Providers manage deeply personal information: biometric signals, diagnostic data, and medical records. Any breach can result not only in financial losses but also in the destruction of patient trust.

ISO 27001 certification provides digital health providers with:

• Assurance to partners: Proves that all systems and workflows comply with international security standards.
• Regulatory alignment: Complements GDPR and HIPAA compliance requirements.
• Operational resilience: Reduces risks of downtime or data corruption.
• Competitive advantage: Demonstrates reliability in an increasingly crowded health tech landscape.

For digital health organizations, insurers, and clinical research partners, working with an ISO-certified provider minimizes regulatory friction and accelerates collaboration.

What the ISO 27001 Framework Covers

The ISO 27001 standard goes beyond technical measures like encryption or access controls. It shapes the everyday habits, mindsets, and culture of everyone in the organization, so that security becomes second nature. Key components include:

• Information Security Policies: Formal rules governing data protection and employee conduct.
• Risk Assessment and Mitigation: Continuous evaluation of vulnerabilities and risk management strategies.
• Data Access Controls: Role-based permissions to ensure only authorized users can access sensitive information.
• Incident Response Plans: Clear procedures for identifying, reporting, and resolving security incidents.
• Ongoing Monitoring and Continuous Improvement: Regular internal audits and policy updates to maintain compliance.

When organizations put these principles into their daily routines, they create a lasting base for strong data protection and ongoing innovation.

What Are The Steps to Achieving ISO Certification

Getting ISO 27001 certified takes careful planning, thorough documentation, and involvement from the whole company. The process usually includes:

1. Initial Assessment: Understanding current security posture, identifying gaps, and defining scope.
2. Developing the ISMS: Creating and implementing a comprehensive Information Security Management System.
3. Documentation: Establishing clear policies, risk assessments, and procedures that align with ISO requirements.
4. Internal Audits: Conducting preliminary reviews to ensure readiness for certification.
5. External Audit: Undergoing an independent assessment from an accredited certification body.
6. Certification & Continuous Improvement: Once approved, organizations must maintain compliance through ongoing reviews, monitoring, and employee training.

For Thryve, this journey was about more than passing audits. It meant making information security a core part of every product and process, so it stays central to daily work.

What Are The Benefits Across Stakeholders

For Insurers and Providers

ISO certification means confidence. Insurers and healthcare providers can trust that their data-sharing partnerships are protected by verified security protocols, reducing exposure to breaches or compliance penalties.

For Digital Health Startups

ISO 27001 certification can be a game-changer for digital health startups. It shows investors, clients, and regulators that you’ve built responsible, trustworthy data management practices that can grow with your company. This confidence often translates to more opportunities in funding rounds and procurement processes, helping you stand out in a crowded market.

For Patients and End Users

When patients use digital health apps or wearable-based platforms, they share intimate details about their lives. ISO 27001 ensures that this information remains private, protected, and used responsibly.

What Are The Challenges Along the Way

Achieving ISO 27001 certification comes with its own set of challenges, especially for fast-scaling digital health providers managing large volumes of sensitive data.

• Complex Data Ecosystems: Integrating multiple health data sources (wearables, EHRs, and APIs) requires robust data governance.
• Employee Alignment: Ensuring every team member, from engineering to customer support, understands their role in maintaining security compliance.
• Documentation Load: The process demands detailed documentation, audits, and evidence of consistent implementation.
• Evolving Threat Landscape: Cyber threats evolve faster than regulations, so maintaining compliance means proactive, not reactive, security practices.

By overcoming these challenges, a company shows its commitment to long-term trust and strong operations. For Thryve, this process made both its internal culture and external partnerships stronger.

Thryve’s Journey to ISO 27001 Certification

At Thryve, achieving ISO 27001 certification is personal. It’s about earning the trust of every patient, partner, and client who relies on our platform. This milestone is threaded into our mission to make digital health not just secure, but truly empowering for everyone involved.

Our certification isn’t just a badge on the website. We want to show our ongoing commitment that reaches every corner of our ecosystem, from infrastructure and API design to the way we handle support requests. Getting here took dedication from our whole team, who:

• Embraced continuous learning through regular internal and external audits.

• Invested in training, so every employee understands how to protect data and respect privacy.

• Constantly assess risks and adapt strategies to stay ahead.

• Welcomed independent review by accredited ISO auditors to ensure we meet and exceed the highest standards.

We see ISO 27001 as a foundation that works hand-in-hand with GDPR and HIPAA, giving our clients and their users peace of mind. Every data point, whether it comes from a wearable or a medical device, is treated with care and processed under strict, transparent security protocols.

How Thryve Shapes Trust Through Certification

Digital health innovation thrives on trust, and trust is built through transparency and compliance. ISO 27001 certification proves that an organization doesn’t just say it values privacy and security; it demonstrates it through measurable, externally validated standards.

As digital health continues to expand, from remote patient monitoring to AI-powered diagnostics, compliance and interoperability will define success. Providers who prioritize robust data protection frameworks will not only safeguard their systems but also gain the confidence of partners, regulators, and patients alike. With Thryve’s API, health organizations can innovate boldly, knowing their foundation is secure.

At Thryve, every feature, integration, and partnership is underpinned by ISO 27001, GDPR, and HIPAA compliance. This ensures our clients can focus on building better health solutions, knowing their data and their users’ trust are always protected by:

• Seamless Device Integration: Easily connect over 500 other health monitoring devices to your platform, eliminating the need for multiple integrations.
• Standardized Biometric Models: Automatically harmonize biometric data streams, including heart rate, sleep metrics, skin temperature, activity levels, and HRV, making the data actionable and consistent across devices.
• GDPR-Compliant Infrastructure: Ensure full compliance with international privacy and security standards, including GDPR and HIPAA. All data is securely encrypted and managed according to the highest privacy requirements.  

Want to learn how Thryve’s ISO 27001-certified infrastructure can strengthen your digital health platform?
‍Book a demo and explore how we make security a catalyst for innovation.