The CNIL‘s screening rule sounds simple: hit two of the nine high-risk criteria, and you owe a full Data Protection Impact Assessment (DPIA). The trouble starts when you hit one or none, because the GDPR never says that skipping the DPIA means skipping assessment altogether. Plenty of processing falls outside the CNIL’s screening rules: operations below the two-criteria threshold, activities on the CNIL’s exemption list, processing already covered by an earlier DPIA, and controllers who answer to a different supervisory authority altogether. In every one of those cases, the Article 35 GDPR DPIA obligation may fall away while the risk assessment obligations under Articles 24 and 32 stay exactly where they were. This article maps the scenarios where CNIL criteria don’t apply and what a defensible assessment strategy looks like when they don’t. DPIA vs General Risk Assessment: Core Distinctions Under GDPR These two assessments get conflated constantly, and the mix-up has real consequences. They rest on different legal bases, serve different purposes, and trigger under different conditions. Article 35 GDPR requires a DPIA where processing is “likely to result in a high risk” to people’s rights and freedoms, and it requires the assessment before processing begins. The DPIA looks outward. It evaluates the necessity and proportionality of the processing and the risks it creates for data subjects: discrimination, identity theft, financial loss, reputational damage, loss of control over personal data. The measuring stick throughout is harm to people. Article 32 GDPR requires controllers and processors to put in place technical and organizational measures (TOMs) appropriate to the risk of the processing. You can’t know what’s appropriate without assessing that risk first, so Article 32 carries an implicit risk assessment duty for every processing operation you run, high risk or not. Its focus is security: the confidentiality, integrity, availability, and resilience of the systems handling personal data. Article 24 completes the picture by making the controller responsible for implementing measures proportionate to risk and able to demonstrate compliance. That’s the accountability principle at work. So risk assessment is universal, and the DPIA is the escalated version you reserve for processing that crosses the high-risk line. The real question is which assessment to run and how deep to go. You don’t need a six-figure budget to be GDPR compliant. You need a clear plan and someone to do the work. Affordable GDPR Compliance Services Book a Free GDPR Consultation The CNIL Criteria: A Quick Recap The Article 35(3) Baseline and the 9 Criteria Article 35(3) names three situations where a DPIA is always mandatory: systematic and extensive automated evaluation of individuals, including profiling, with legal or similarly significant effects; large-scale processing of special categories of data (Article 9) or criminal conviction data (Article 10); and large-scale systematic monitoring of a publicly accessible area. Beyond those, the WP29 guidelines on DPIAs (WP248 rev.01), endorsed by the European Data Protection Board (EDPB), list nine criteria that indicate likely high-risk processing: evaluation or scoring, including profiling; automated decision-making with legal or similarly significant effect; systematic monitoring; sensitive data or data of a highly personal nature; processing on a large scale; matching or combining datasets; data concerning vulnerable data subjects (employees, patients, children); innovative use or application of new technological or organizational solutions; and processing that prevents data subjects from exercising a right or using a service or contract. The “Two Criteria” Threshold Rule The CNIL’s position is that processing meeting at least two of the nine criteria requires a DPIA as a general rule. WP248 leaves room on both sides of that line: a controller can conclude that processing meeting two criteria still isn’t high risk, and in some cases a single criterion is enough to trigger the obligation. Either way, the reasoning has to be documented. Where there’s genuine doubt, the CNIL’s advice is simple: do the DPIA. CNIL’s List of Processing Operations Requiring a DPIA The CNIL also maintains a mandatory list under Article 35(4), adopted through Deliberation No. 2018-327 of October 11, 2018. It names 14 types of processing that require a DPIA outright, including systematic employee monitoring, whistleblowing schemes, profiling that can exclude people from a contract, and large-scale processing of health data. If your processing appears on this list, you can skip the criteria math because the DPIA is mandatory regardless. Insider Note: The CNIL’s sectoral “referentials” do more work than most DPOs realize. If your processing fully complies with an applicable referential, the CNIL accepts the position that residual risk isn’t high, which takes Article 36 prior consultation off the table. Checking for a referential before scoping a DPIA can remove the most painful step of the entire process. When CNIL Criteria Don’t Apply: Key Scenarios Processing Falling Below the Two-Criteria Threshold Most B2B processing lives here. A standard CRM, a newsletter list, routine supplier management: these might touch one criterion (large scale, perhaps) without hitting a second. No DPIA is required, but the screening itself is a compliance artifact. Record which criteria you tested, what you concluded, and why. If the CNIL inspects, the absence of a DPIA is defensible only when the screening decision is on paper. Operations on CNIL’s Exemption List Article 35(5) lets supervisory authorities publish “whitelists” of processing that doesn’t require a DPIA. The CNIL adopted one in 2019 after an EDPB opinion, covering categories such as routine HR management in organizations with fewer than 250 employees (without profiling, biometrics, or sensitive data), badge-based physical access control without biometrics, and time management systems that don’t process biometric data. France is one of only a few member states with a formal whitelist, which matters for cross-border groups: the same HR system can be exempt in France and assessable case by case in Luxembourg. Processing Authorized by Specific Legal Provisions Article 35(10) carves out processing based on a legal obligation or public interest task under Article 6(1)(c) or (e), where the legal basis regulates the specific operation and a general impact assessment was already carried out when that law was adopted. It’s a narrow
Researchers who buy second-hand drives off online marketplaces keep finding the same thing: live data. A widely cited study by Blancco Technology Group found that 42% of used drives sold on eBay still held recoverable information, including financial records and personal data the previous owners assumed was long gone. The drives were not hacked; they were thrown away by organizations that treated deleting a file as the same thing as destroying it. Secure data disposal is where many compliance programs fail. ISO 27001, SOC 2, and GDPR all demand it, but they describe it in different languages, enforce it through different mechanisms, and punish failure in very different ways. This article sets out what each framework requires, where the requirements overlap, and how to run a single disposal program that satisfies all three at once. Why Secure Data Disposal Matters Across Compliance Frameworks Disposal is the last link in the data lifecycle, and the easiest one to skip. An organization can run flawless access controls, encryption, and monitoring for years and still cause a reportable breach the moment one unwiped laptop leaves the building. A recoverable drive in a recycling skip is functionally identical to an open database on the internet, and auditors and regulators know it. Most disposal failures are unforced errors: a control that was already written into policy but never carried through to the actual hardware. The gap between having a disposal policy and proving this specific drive was destroyed is exactly where audits and breach investigations live. Defining Secure Data Disposal: Key Terms and Concepts What Is Secure Data Disposal? Secure data disposal is the end-to-end process of removing data and the equipment that holds it from active use, in a way that prevents its recovery. It covers the full lifecycle end: deletion of data while a system is still live, sanitisation of media that will be reused, physical destruction of media that will not, and the safe handling of equipment that is recycled, returned to a lessor, or sold. Disposal is the goal. The methods are how you get there. What Is Secure Data Destruction? Secure data destruction is the subset of disposal that renders media permanently unusable or its contents mathematically irretrievable. Shredding a drive, pulverising it, incinerating it, or destroying the encryption keys that make an encrypted disk readable are all forms of destruction. Destruction is one route to disposal, and it is the right route when the data is highly sensitive, or the media will never be reused. Secure Data Disposal vs. Secure Data Destruction: What Is the Difference? The distinction matters more than it looks. Disposal is the outcome you owe to every framework: data gone, unrecoverable, equipment handled appropriately. Destruction is just one of the methods. You can dispose of data without destroying the hardware by sanitising a drive thoroughly enough to reuse it. Confusing the two leads to two classic mistakes: destroying assets that could have been securely wiped and reused, and assuming a quick deletion counts as disposal when it does not. Important: Emptying the recycle bin, formatting a drive, or hitting delete does not dispose of data under any of these frameworks. Standard deletion only removes the pointer to the data; the bits remain until they are overwritten. Every framework discussed here expects the data to be unrecoverable, which is a far higher bar than not visible. What ISO 27001 Requires for Secure Data Disposal ISO/IEC 27001 handles disposal through a small cluster of Annex A controls that auditors read as a single process rather than in isolation. The two controls that do most of the work are 7.14 and 8.10. For a deeper look at how these controls fit into a broader compliance program, see our ISO 27001 implementation guide. ISO 27001 Annex A 7.14: Secure Disposal or Re-Use of Equipment Annex A 7.14 is a physical control. Before any equipment is disposed of or reused, the organisation must check whether it holds information assets or licensed software and ensure those are permanently erased or the media physically destroyed. It applies to servers, laptops, desktops, mobile devices, printers, network gear, and any storage media: if it ever processed information, it is in scope. The control replaces the older 2013 clause 11.2.7 and adds explicit expectations around removing identifying markings and handling end-of-occupancy scenarios. ISO 27001 Control 8.10: Information Deletion Annex A 8.10 is a technological control, and it focuses on the data rather than the box. It requires information stored in systems, devices, or media to be deleted when it is no longer required, and rendered unrecoverable. The cleanest way to keep these straight: 8.10 governs the data while it is in use or reaches its retention limit; 7.14 governs the hardware at end of life. Most retention-driven deletion sits under 8.10; most decommissioning sits under 7.14. ISO 27001 Control 8.12: Data Leakage Prevention and Its Role in Disposal Control 8.12 is rarely filed under disposal, but improperly discarded media is one of the oldest data leakage channels there is. A drive that leaves your control with recoverable data on it is a leak, regardless of how it left. Treating disposal as part of your leakage prevention posture forces the right question at the right time: what could walk out the door on this device, and has it actually been removed? Physical Destruction and Irretrievable Erasure Under ISO 27001 ISO 27001 offers two broad routes: physically destroy media that holds information, or erase and overwrite it so retrieval by a malicious party is precluded. The standard cross-references ISO/IEC 27040 for detailed sanitisation methods. The unifying requirement is that recovery should be impractical, not merely inconvenient. Deletion alone never satisfies this. Overwriting, Full-Disk Encryption, and Other Approved Methods Overwriting user-accessible storage with multiple passes is acceptable for many sensitivity levels. Full-disk encryption changes the economics of disposal entirely: if a device is encrypted from day one and the keys are properly managed, secure disposal can be as simple as destroying the keys, a technique known as
HIPAA and GDPR are the two most consequential data protection frameworks any healthcare or technology organisation is likely to encounter. They share a common purpose, protecting sensitive personal data, but they differ significantly in scope, enforcement mechanisms, and compliance obligations. For organisations operating across the Atlantic, understanding where they align, where they clash, and how to satisfy both simultaneously is not optional. It is a legal necessity. What Is HIPAA? The Health Insurance Portability and Accountability Act was enacted by the U.S. Congress in 1996. Its original purpose was to modernise the flow of healthcare information and ensure the portability of health insurance coverage. Over time, it became primarily known for its data protection requirements, administered by the U.S. Department of Health and Human Services (HHS) and enforced by the Office for Civil Rights (OCR). HIPAA is built around three core rules. The Privacy Rule governs how Protected Health Information (PHI) may be used and disclosed. The Security Rule sets standards for safeguarding electronic PHI (ePHI). The Breach Notification Rule establishes mandatory reporting timelines when PHI is compromised. Who Needs to Be HIPAA Compliant? HIPAA applies to covered entities, healthcare providers, health plans, and healthcare clearinghouses, and to their business associates: any third-party organisation that handles PHI on their behalf. If you build software that processes patient data for a U.S. hospital, you are a business associate. If you store medical records in the cloud for an insurance company, you are a business associate. A Business Associate Agreement (BAA) is the formal contract that governs this relationship. What Types of Data Does HIPAA Protect? HIPAA protects Protected Health Information (PHI): any individually identifiable information relating to a person’s past, present, or future physical or mental health condition, the provision of healthcare, or the payment for healthcare. This includes names, dates of birth, Social Security numbers, medical record numbers, and any data that could be used to identify a patient in connection with their health. Electronic PHI, the subset stored or transmitted digitally, is subject to the Security Rule’s additional technical requirements. What Is GDPR? The General Data Protection Regulation came into force across the European Union on 25 May 2018, replacing the 1995 Data Protection Directive. It is the world’s most comprehensive data privacy law, and its extraterritorial reach means it extends well beyond Europe’s borders. The GDPR is enforced by national Data Protection Authorities (DPAs) and coordinated at the European level by the European Data Protection Board (EDPB). Unlike HIPAA, GDPR is not sector-specific. It applies to any organisation processing the personal data of EU residents, regardless of industry. Who Needs to Be GDPR Compliant? Any organisation that processes the personal data of individuals located in the European Union, regardless of where the organisation is based. A U.S. hospital treating European patients, a SaaS company offering services to German users, or a health app collecting data from French residents all fall within GDPR’s scope. The regulation applies to both data controllers (organisations that determine how and why data is processed) and data processors (third parties that process data on a controller’s behalf). What Types of Data Does GDPR Protect? GDPR protects all personal data: any information relating to an identified or identifiable natural person. Health data is explicitly designated a special category under GDPR Article 9, commanding heightened protection alongside biometric data, genetic data, racial or ethnic origin, religious beliefs, and sexual orientation. HIPAA vs GDPR: Key Differences at a Glance Feature HIPAA GDPR Jurisdiction United States only EU + extraterritorial reach Sector Healthcare only All sectors Regulatory body HHS / OCR National DPAs / EDPB Data covered PHI only All personal data Consent model Treatment-based exceptions Explicit consent required Breach notification 60 days (proposed: 72 hours) 72 hours Max fine $1.9M per violation category/year €20M or 4% of global turnover DPO required No Sometimes Right to erasure Limited Yes Scope and Geographic Reach HIPAA’s reach is defined by entity type: it applies to covered entities and business associates operating within the United States. Whether a patient holds EU citizenship is irrelevant to HIPAA jurisdiction. What matters is whether the organisation providing care or processing health data operates within the U.S. healthcare system. GDPR’s reach is defined by the location of the data subject, not the organisation. Article 3 of the GDPR gives it explicit extraterritorial effect. If your organisation targets or monitors EU residents, GDPR applies, regardless of where you are headquartered, where your servers are located, or what industry you operate in. Types of Data Protected: Personal Data vs Protected Health Information (PHI) This is the sharpest structural difference between the two frameworks. HIPAA is focused exclusively on health data in the context of healthcare delivery or payment. GDPR covers all personal data, from email addresses and IP addresses to medical records and genetic profiles. Health data under GDPR is a subset of the broader personal data category, not the totality of it. An organisation that is fully HIPAA-compliant may still be in violation of GDPR if it mishandles employee data, marketing data, or website analytics. Legal Basis for Data Processing GDPR requires organisations to identify a valid legal basis before processing any personal data. For health data, that typically means explicit consent or one of the specific derogations in Article 9(2), such as processing necessary for medical diagnosis or the provision of healthcare. This is a meaningful threshold; pre-ticked boxes, bundled consent, or vague terms of service do not meet GDPR’s standard. HIPAA takes a different approach. It permits covered entities to use and disclose PHI for treatment, payment, and healthcare operations without obtaining patient consent. Authorisation is required only in specific circumstances, such as disclosures for marketing purposes or release of psychotherapy notes. Important: GDPR’s explicit consent requirement creates real friction for U.S. healthcare organisations treating EU patients. A hospital cannot rely on its standard HIPAA-compliant intake forms to satisfy GDPR. The legal bases must be documented separately, and consent forms must meet the GDPR’s granularity requirements. Regulatory Authority and Enforcement HHS OCR is
Plenty of companies treat an ISO 27001 certificate as proof of GDPR compliance. It is not. The two frameworks overlap heavily, but they answer different questions, and the gap between them is exactly where regulators tend to look. ISO 27001 tells you how to build a defensible security program. GDPR tells you what the law expects when that program touches personal data. Run one without understanding the other, and you will either over-engineer security you do not strictly need, or miss privacy obligations that carry real financial exposure. This article maps where ISO 27001 and GDPR meet, where they part ways, and how to run them as a single coordinated effort rather than two competing projects. What Is ISO 27001? ISO/IEC 27001 is the international standard for an Information Security Management System, or ISMS. The current edition is ISO 27001:2022. It is not a checklist of technical fixes. It is a management framework: a structured, repeatable way to identify information security risks, decide how to treat them, document those decisions, and improve over time. Clauses 4 to 10 of the standard define the mandatory ISMS requirements, covering leadership, risk assessment, internal audit, and management review. Annex A then lists 93 controls grouped into four themes: organisational, people, physical, and technological. You do not implement all 93 by default. You select the controls that address your assessed risks and justify your choices in a document called the Statement of Applicability. Certification against ISO 27001 is voluntary and is granted by an accredited third-party body after an audit. What Is GDPR? The General Data Protection Regulation is European Union law. It has been applied since 25 May 2018, and it applies to any organisation that processes the personal data of people in the EU, wherever that organisation is based. GDPR is fundamentally about the rights of individuals, not just the security of data. It grants people rights over their personal data, including access, correction, erasure and portability. It places obligations on the organisations that decide how data is used (controllers) and those that process it on their behalf (processors). It requires a lawful basis for every processing activity, mandates breach notification, and demands transparency about what happens to people’s information. You do not implement GDPR and receive a certificate. You obey it, and a regulator decides whether you have. Key Differences Between ISO 27001 and GDPR Scope and Purpose ISO 27001 protects all information assets an organisation holds: intellectual property, financial records, operational data, source code and, yes, personal data. Its purpose is the confidentiality, integrity and availability of information in general. GDPR is narrower in one sense and broader in another. It covers only personal data of individuals in the EU, but it protects the person behind the data, not merely the data itself. A system can be flawlessly secure and still violate GDPR. Legal Obligation vs. Voluntary Certification This is the difference that catches people out. GDPR is binding law. If you process EU personal data, compliance is not optional, and there is no opting out. ISO 27001 is a voluntary standard. Organisations pursue it for assurance, for competitive advantage, and because customers increasingly demand it. Crucially, there is no such thing as a GDPR certificate. Regulators assess compliance through investigation and enforcement, not through a badge you can display. Penalties for Non-Compliance GDPR fines run on two tiers under Article 83. Less severe infringements — such as failures around records of processing or breach notification — can reach €10 million or 2% of global annual turnover, whichever is higher. The more serious tier, covering breaches of the core processing principles and data subject rights, can reach €20 million or 4% of global annual turnover. Failing an ISO 27001 audit carries no legal fine at all. The consequence is commercial: you do not get the certificate, or you lose it, and that can cost you contracts. How ISO 27001 and GDPR Align Despite their different purposes, the two frameworks were built on compatible logic, which is why running them together works. Both treat information security as central. GDPR Article 32 requires “appropriate technical and organisational measures” to secure personal data. That phrasing is almost a direct description of what an ISO 27001 ISMS produces. The controls an organisation selects for confidentiality and access already serve the regulation’s security expectations. Both are risk-based. ISO 27001 starts every control decision from a risk assessment. GDPR expects the same proportionality: the measures you apply should match the sensitivity of the data and the likelihood and severity of harm. One risk methodology can serve both, provided you assess personal data processing risks alongside broader security risks. Both demand incident response. ISO 27001’s incident management controls require organisations to detect, assess and respond to security events. GDPR Article 33 requires notifying the supervisory authority of a personal data breach within 72 hours of becoming aware of it. The ISO process is the engine that makes the GDPR deadline achievable. How ISO 27001 Can Help You Comply With GDPR Four areas of an ISMS do direct, practical work toward GDPR compliance. Asset management. ISO 27001 requires an inventory of information and associated assets, with owners assigned. You cannot protect personal data, respond to access requests, or maintain records of processing if you do not know where that data lives. The asset inventory is the foundation for both frameworks. Access control. Identity management, privileged access controls and the principle of least privilege limit who can see personal data. That directly supports the GDPR requirement to ensure confidentiality and to prevent unauthorised access. Operational security. Logging, malware protection, backup and secure configuration keep personal data accurate, available and resistant to compromise. These map cleanly onto the integrity and availability expectations in Article 32. Techniques such as data masking for GDPR and ISO 27001 also sit within this space, reducing exposure without sacrificing operational utility. Incident management. A defined process for detecting and handling security events gives you the evidence trail and the response capability you need to
