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Certifications, standards, and terminology explained — so you know what we're looking for and why it matters.

When we evaluate a product's security infrastructure, we look for recognized certifications and compliance standards. These aren't just checkboxes — each one represents a specific set of protections for your data, your health information, and your privacy. Here's what they mean.

Security Certifications & Standards

These are the certifications and compliance frameworks we look for when evaluating the Security & Privacy dimension.

SOC 2

Type I & Type II

System and Organization Controls 2 is an auditing standard developed by the American Institute of CPAs (AICPA). It evaluates how well a company protects customer data based on five "Trust Service Criteria": security, availability, processing integrity, confidentiality, and privacy.

Type I

Evaluates the design of controls at a specific point in time. "Are the right safeguards in place?"

Type II

Evaluates the effectiveness of controls over a period (usually 6-12 months). "Are those safeguards actually working?"

Why we look for it: SOC 2 Type II is the gold standard for demonstrating ongoing data protection. A company with this certification has been independently verified to handle your data securely — not just at one point, but continuously.

HIPAA

U.S. Federal Law

The Health Insurance Portability and Accountability Act (1996) is the primary U.S. law governing how health information is stored, shared, and protected. It applies to "covered entities" (healthcare providers, insurers, clearinghouses) and their "business associates."

Important nuance: Most consumer health apps are not legally required to comply with HIPAA — it only applies if the app works with a covered entity (like a hospital or insurer). When a femtech app voluntarily follows HIPAA standards, it's going above and beyond what's legally required — which is a positive signal.

Why we look for it: HIPAA compliance means the company treats your health data with the same rigor as a hospital or doctor's office. Even when not legally required, voluntary HIPAA compliance shows a serious commitment to protecting sensitive health information.

ISO 27001

International Standard

An international standard for Information Security Management Systems (ISMS), published by the International Organization for Standardization. It provides a systematic framework for managing sensitive company and customer information through risk assessment, security controls, and continuous improvement.

Certification requires an external audit by an accredited body and must be renewed every three years, with annual surveillance audits in between.

Why we look for it: ISO 27001 is globally recognized and shows that a company has a comprehensive, audited security management program — not just individual security features, but an entire organizational approach to protecting data.

GDPR

EU Regulation

The General Data Protection Regulation (2018) is the European Union's comprehensive data privacy law. It gives individuals rights over their personal data — including the right to access, correct, delete, and port their data — and imposes strict requirements on how companies collect, store, and process personal information.

Key user rights

Right to access, rectification, erasure ("right to be forgotten"), data portability, and the right to object to processing.

Key company obligations

Lawful basis for processing, data protection by design, breach notification within 72 hours, and appointment of a Data Protection Officer (where required).

Why we look for it: GDPR compliance means strong user rights and data protections. Even for non-EU companies, voluntarily following GDPR principles indicates a higher standard of privacy. Products that store data on EU servers under GDPR governance provide some of the strongest privacy protections available.

FDA Clearance & Approval

U.S. Regulatory

The U.S. Food and Drug Administration regulates medical devices, including software that makes clinical claims. There are two main pathways to market:

510(k) Clearance

Demonstrates the device is "substantially equivalent" to a legally marketed device. Most common pathway for health apps. Lower bar than full approval.

De Novo Classification

For novel devices with no existing equivalent. Requires demonstrating safety and effectiveness for a new type of product. Higher bar than 510(k).

Important nuance: "FDA cleared" is not the same as "FDA approved." Clearance (510(k)) means substantially equivalent to an existing device. Approval (PMA) is the most rigorous pathway, typically for higher-risk devices. Many apps use "FDA cleared" loosely — we verify the actual regulatory status.

Why we look for it: FDA oversight means the product's clinical claims have been reviewed by a regulatory body. It's not a guarantee of accuracy, but it provides accountability that unregulated wellness apps don't have.

CE Marking

EU Regulatory

Conformité Européenne marking indicates that a product meets EU health, safety, and environmental requirements. For medical devices (including health software), this is regulated under the Medical Device Regulation (MDR 2017/745), which replaced the older Medical Device Directive in 2021.

Class I

Lowest risk. Self-certification by the manufacturer. Most general wellness apps fall here.

Class IIa / IIb

Medium risk. Requires assessment by a "Notified Body" (independent auditor). Diagnostic or monitoring software.

Class III

Highest risk. Full clinical investigation and Notified Body audit required. Implantable or life-supporting devices.

Why we look for it: CE marking under the MDR is the EU equivalent of FDA regulation. It means the product has been assessed against safety and performance requirements. The class level tells you how thoroughly it was reviewed.

Encryption Standards

Technical

Encryption converts your data into unreadable code that can only be decoded with the right key. We look for two types:

In transit (TLS/SSL)

Protects data as it moves between your device and the company's servers. The "https://" in a URL means TLS is active. This is a baseline expectation.

At rest (AES-256)

Protects data while it's stored on servers. AES-256 is the gold standard — used by governments and banks. Without it, a server breach exposes raw data.

Why we look for it: Encryption is the foundation of data security. We verify that companies explicitly state their encryption practices — both in transit and at rest — rather than vaguely claiming "your data is secure."

Quick Reference

Standard Scope Required? Verified by
SOC 2 Type II Data security controls Voluntary Independent CPA firm
HIPAA Health data privacy (U.S.) Required for covered entities; voluntary for most apps Self-assessed (no certification body)
ISO 27001 Information security management Voluntary Accredited certification body
GDPR Data privacy (EU) Required for EU users Data Protection Authorities
FDA 510(k) Medical device safety (U.S.) Required for medical device claims FDA review
CE Marking (MDR) Medical device safety (EU) Required for EU market Notified Body (for Class IIa+)