Data Privacy & Protection
This 1996 US federal law protects sensitive patient health information from being disclosed without consent.
What is HIPAA (Health Insurance Portability and Accountability Act)?
This FDA abbreviation describes software intended to be used for medical purposes without being part of actual hardware medical device.
What is SaMD (Software as a Medical Device)?
According to a 2023 Law Library of Congress survey, approximately this many jurisdictions worldwide have legislation specifically referring to AI.
What is 40?
This type of diagnostic device is developed and used within a single laboratory and not sold or distributed to others.
What is an LDT (Laboratory-Developed Test)?
This European regulation sets comprehensive data privacy standards and gives individuals more control over their personal data.
What is GDPR (General Data Protection Regulation)?
This is the most stringent type of FDA device marketing application, typically required for class III medical devices.
What is PMA (Premarket Approval)?
AI-ML-based devices tend to be approved in this continent before the United States, possibly due to less rigorous evaluation.
What is Europe?
These committees ensure ethics oversight, conduct risk-benefit analysis, and require transparency for AI research involving human data.
What are IRBs (Institutional Review Boards)?
Under HIPAA, this type of agreement must be in place when a healthcare entity works with external parties that have access to PHI.
What is a Business Associate Agreement (BAA)?
This FDA clearance pathway demonstrates that a device is at least as safe and effective as a legally marketed predicate device.
What is 510(k) Clearance?
This country has established itself as a global leader in AI with regulations like the Cybersecurity Law and New Generation AI Development Plan.
What is China?
This executive order requires agencies to increase algorithmic transparency and include human oversight for AI in healthcare.
What is President Biden's Executive Order on AI?
HIPAA requires these three types of safeguards to protect PHI: administrative, physical, and this.
What are technical safeguards?
This new FDA process outlines how changes to software products will be managed post-market, particularly critical for AI-ML technologies.
What is PCCP (Predetermined Change Control Plan)?
This Canadian government-led program advocates for the responsible development and use of AI.
What is the Pan-Canadian AI Strategy?
This FDA-encouraged practice ensures that AI-ML systems are transparent, explainable, and reliable throughout the product lifecycle.
What is Good Machine Learning Practice?
This federal policy, often called the 'Common Rule,' governs ethics and safeguards for the use of human subjects in research.
What is the Federal Policy for the Protection of Human Subjects?
The FDA piloted this innovative program from 2017 to 2022 to precertify developers and streamline the regulatory process for software.
What is the Software Precertification Program?
This global network of medical device regulators focuses on AI in the context of medical devices and promotes international cooperation.
What is the International Medical Device Regulators Forum (IMDRF)?
In May 2024, the FDA published new regulations placing these tests, previously under CLIA, within the medical device regulatory framework.
What are LDTs (Laboratory-Developed Tests)?