A contract required under US HIPAA between a covered entity and any vendor that handles protected health information on its behalf. The BAA binds the vendor to the same safeguards and breach-notification duties, and is a prerequisite before a vendor or AI service may process PHI.
Building the controls and records a regulation expects directly into a system, so evidence of how the rules were followed is produced by the system itself. It replaces the scramble of assembling proof by hand at audit time.
The requirement that data be stored and processed in a specific country or region, often to satisfy a law or contract. For AI deployments it shapes which models, cloud regions, and providers are permissible, since sending data to an out-of-region service can breach the rule.
Removing enough from health information that it is no longer protected health information and falls outside the US HIPAA Privacy Rule. 45 CFR 164.514 allows exactly two routes: expert determination, where a qualified person documents that the re-identification risk is very small, and safe harbor, where 18 specified identifiers are removed and there is no actual knowledge that what remains could identify someone. A limited data set, which keeps dates and some geography under a data use agreement, is not de-identified data. Treating the two as the same is a common and visible mistake.
A European Union regulation that governs AI systems using a risk-based approach, placing stricter obligations on higher-risk uses and prohibiting a narrow set of practices outright. It applies broadly to providers and deployers whose systems are used in the EU, and is phasing in over several years.
The international standard for an Artificial Intelligence Management System, published in December 2023. It is a management system standard, so it certifies how an organization governs AI, not whether any individual model is safe, accurate, or fair. That distinction is the most useful thing to know about it. Its Annex A carries 38 controls across 9 control objectives, selected against the organization`s own risk and impact assessment rather than applied as a mandatory checklist. Unlike SOC 2, it is a genuine certification, issued by an accredited body after a two-stage audit. Related standards include ISO/IEC 42005 on AI system impact assessment, ISO/IEC 42006 on the bodies that certify, and ISO/IEC 27001, which secures the data while 42001 governs the AI.
The US HIPAA Privacy Rule standard, at 45 CFR 164.502(b) and 164.514(d), that limits any use or disclosure of protected health information to the least needed to accomplish the purpose. It is the exact regulatory hook for silent over-collection by AI: an agent granted access to a full patient record when its task needed three fields is a minimum-necessary problem before it is anything else, whether or not the extra data is ever read.
A voluntary framework published as NIST AI 100-1 in January 2023 by the US National Institute of Standards and Technology, to help organizations identify, assess, and manage the risks of AI systems. Its core is four functions: govern, who owns AI risk and what the policy says; map, what the system is for and what could go wrong; measure, how risk is evaluated and monitored; and manage, how risk is treated, escalated, and recovered from. The four run continuously and iteratively rather than as sequential stages. The framework is sector-agnostic and non-certifiable: there is no such thing as being NIST AI RMF certified.
Individually identifiable health information that is protected under US HIPAA, covering the medical and payment details that can be tied to a specific person. Any AI system that processes PHI inherits HIPAA obligations, including safeguards, access controls, and a signed BAA with the provider.
Information that can identify a specific individual, on its own or combined with other data, such as a name, email, government ID, or device identifier. How PII may be collected, stored, and shared is governed by privacy laws, which constrain what an AI system can do with it.
The prescriptive route to de-identifying health information under 45 CFR 164.514(b)(2): remove 18 specified identifiers of the individual and of relatives, employers, and household members, and hold no actual knowledge that what remains could identify anyone. The 18 include names, geographic units smaller than a state, all date elements except year, contact details, government and account and device identifiers, biometrics, and full-face images. Two details practitioners recognize: the first three digits of a ZIP code may be kept only if the area they cover holds more than 20,000 people, and every age over 89 must be collapsed into a single category of 90 or older.
An attestation report issued by a licensed CPA firm on both the design and the operating effectiveness of a service organization`s controls across a period, typically three to twelve months. A Type I covers design at a single point in time and can be satisfied by a written policy and a screenshot. A Type II cannot: it requires a population of dated artifacts covering the whole observation window, from which the auditor draws a sample. This is why ungoverned AI fails audits. If an agent took actions during the period and no dated, retrievable record of those actions exists, the control has no population and cannot be tested. SOC 2 is an attestation, not a certification, so nothing is ever SOC 2 certified.
The AICPA criteria a SOC 2 examination is conducted against, currently the 2017 Trust Services Criteria with revised points of focus from 2022. There are five categories: security, availability, processing integrity, confidentiality, and privacy. Security is the common criteria and is always in scope; the other four are elected based on the commitments the organization actually makes. The security category is organized as CC1 through CC9, and for AI deployments the three that matter most are CC6 logical access, CC7 system operations and monitoring, and CC8 change management, because that is where an ungoverned agent shows up as a finding.