As MedDev’s Data Footprint Grows, ISO/IEC 27701 Sets the Standard for Privacy and Trust

Introduction

The medical device (MedDev) ecosystem is awash in sensitive health data. From connected implants and remote monitoring apps to cloud-hosted analytics. That data fuels better diagnostics and outcomes, but it also raises material risks in privacy, security, and regulatory exposure. ISO/IEC 27701 extends information security practices into a Privacy Information Management System (PIMS) so organisations can govern personal data end-to-end, demonstrate accountability, and earn stakeholder trust. The standard can be used with adjacent standards, third-party certification turns internal controls into externally validated assurance for regulators, providers, and patients.

The Rising Privacy Imperative in MedDev

Connected devices, hospital networks, and mobile apps multiply data flows and legal obligations. In parallel, privacy regimes such as the European Union (EU) General Data Protection Regulation (GDPR) heighten expectations for lawfulness, transparency, and accountability. And influence procurement criteria worldwide. For manufacturers and digital health platforms, “good intentions” are no longer sufficient. Leaders must prove privacy by design, by default, and in operation.  

Introducing ISO/IEC 27701: The PIMS Extension to ISO/IEC 27001

When ISO/IEC 27701 was first published in 2019 it was designed to be an extension to ISO/IEC 27001 and specified requirements and provided guidance to establish, implement, maintain, and continually improve their PIMS. This also meant that certification to ISO 27001 (ISMS) was a pre-requisite for obtaining ISO 27701 (PIMS) certification.  With the new version (published in 2025) is now a stand alone management system standard. This allows organisations to obtain certification to ISO/IEC 27701 independently of a certification to ISO/IEC 27001. But yes, organisation can get certified to both standards simultaneously. 

It clarifies roles and controls for organisations acting as personally identifiable information (PII) controllers and PII processors, enabling consistent governance across ecosystems. In short, ISO 27701 operationalises privacy management, potentially in conjunction with an already existing ISMS.  

Why 27701 Matters Now – in Business Terms

• Regulatory readiness. Mapping privacy controls to recognised ISO requirements streamlines audits and supports cross-border operations subject to GDPR-like rules.  
• Trust and market access. Hospitals, payers, and partners increasingly prefer vendors with independent privacy attestations, reducing sales friction. 
• Risk reduction. A PIMS reduces breach, complaint, and enforcement exposure through defined roles, data lifecycle controls, and measurable oversight. 
• Efficiency. Potentially extending an existing ISMS (ISO/IEC 27001) avoids duplicative frameworks and concentrates assurance efforts where they matter most and it also can be easily combined with other Management System standards. 

Core Components of ISO/IEC 27701 (What “Good” Looks Like)

• Governance & accountability. Named privacy leadership, defined responsibilities for PII controllers/processors, escalation paths, and board-level visibility.
• Lawful basis & purpose management. Processes to document purposes, legal bases, data subject rights (access, deletion, portability), and to prove compliance.
• Data lifecycle controls. Policies for collection, minimisation, retention/disposal, international transfers, and third-party management.
• Risk & impact assessment. Privacy risk assessments and privacy impact assessments for new or changed processing, especially for sensitive health data.
• Rights handling & transparency. Repeatable mechanisms to fulfil requests and provide intelligible notices and records of processing.
• Monitoring & improvement. KPIs, internal audits, corrective actions, and management reviews to sustain performance over time. 

Implementing ISO/IEC 27701 in a MedDev Organisation

1. Anchor privacy in strategy. Charter a privacy steering group that includes Quality/Regulatory, Security, Clinical, and Product leaders.
2. Scope and inventory. Identify all PII processing (devices, apps, cloud platforms, vendors), controller/processor roles, and jurisdictions.
3.  Gap assessment. Compare current practices to ISO 27701. If you have already and ISMS then leverage your ISMS artifacts (risk methods, incident response, asset inventories) to accelerate.
4. Build the PIMS. Document policies/procedures for lawful basis, data subject rights, DPIAs/PIAs, retention schedules, vendor due diligence, and international transfer controls.
5. Operationalise. Train teams, embed privacy checkpoints in design controls and change management, and establish metrics and dashboards.
6. Independent certification. Select a certification body accredited to ISO/IEC 17021-1 for management systems audits. If already certified to ISO/IEC 27001 then stage the audit to align with your ISO/IEC 27001 cycle.  

How ISO 27701 Fits With Adjacent ISO Standards

• ISO 13485 – Quality Management for Medical Devices: Aligns privacy controls with design controls, traceability, and post-market surveillance for devices and companion software.  
• ISO/IEC 27001 – Information Security Management System (ISMS): Security foundation (access, crypto, logging, incident response) that ISO 27701 extends with privacy-specific requirements.  
• ISO 22301 – Business Continuity Management System (BCMS): Ensures privacy operations (rights handling portals, consent systems, breach notification workflows) remain available during disruption.  
• ISO/IEC 42001 – Artificial Intelligence Management System (AIMS): Coordinates privacy with model governance (training data provenance, explainability, and risk) in AI-enabled devices and platforms via robust Risk and Impact analysis.  
• ISO 56001 – Innovation Management System (IMS): Connects privacy requirements to portfolio decision-making so new concepts are viable in regulated markets. 

Common Pitfalls and Practical Fixes 

• “Security = privacy”. Security is necessary but not sufficient. Lawful processing, rights handling, and transparency require distinct PIMS controls. 
• Late-stage retrofits. Bolting on privacy at release time drives rework. Embed ISO 27701 gates in design controls and supplier onboarding. 
• Opaque vendor chains. Require processor/sub-processor transparency and contractually bind ISO 27701-aligned controls and audit rights. 
• Inconsistent records. Maintain authoritative records of processing activities, data flows, and retention rules to survive audits and investigations. 
• Stagnant programs. Use KPIs (request fulfilment times,  Data Protection Impact Assessment completed, transfer assessments, incidents resolved) and management reviews to drive improvement. 

The Strategic Upside of Third-Party Certification

• Independent validation. Certification signals to customers and regulators that privacy is governed by a recognised, auditable standard (PIMS), not just policy statements.  
• Regulatory credibility. A certified PIMS demonstrates accountability under GDPR’s principles of lawfulness, fairness, and transparency, easing scrutiny.  
• Operational discipline. Certification cycles institutionalise audits, metrics, and corrective actions, reducing variance across products and geographies. 
• Commercial advantage. Certification becomes a procurement differentiator and unlocks data-sharing partnerships where trust is decisive. 

Endnote

Privacy has become a clinical, regulatory, and commercial imperative in MedDev. ISO/IEC 27701 gives organisations a proven way to operationalise privacy together with their security programs, translating legal obligations into day-to-day controls and evidence. When integrated with ISO/IEC 27001, ISO 22301, ISO 13485, ISO/IEC 42001, and ISO 56001, the result is a coherent, scalable management system that protects patients, accelerates approvals, and builds durable market trust. Pursuing third-party certification converts internal intent into externally verified assurance.  

References

ISO 27001: Information Security Management Systems

ISO 27701: Privacy Information Management Systems

ISO 22301: Business Continuity Management Systems

ISO 42001: Artificial Intelligence Management Systems

ISO 56001: Innovation Management Systems

ISO 13485: Medical Device Quality Management

IAF – International Accreditation Forum

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