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Documents to review
Controlled substance procedureResearch document type
Compounding SOPResearch document type
Cleaning procedureResearch document type
Inventory procedureResearch document type
Scope questions
Industry alone does not establish legal applicability. Confirm location, activities, role, data and relevant thresholds.
Where does the organization operate, and which regulator, license, permit or contract governs the activity?
Which business activities, data types and organization roles does the document describe?
Do the relevant thresholds or exceptions change which requirements apply?
Unknown answers stay unresolved. Document detection does not answer these questions for you.
A fictional example to explore
This short policy outline demonstrates the document's structure and research questions. It is a navigation example; scans for this profile are not available yet.
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Regulations and frameworks to explore
These are research candidates for this profile. Confirm the exact organization and activity before concluding that a rule applies.
Research only
HIPAA Security, Privacy, and Breach Notification Rules
45 CFR Parts 160 and 164
Applies to covered entities and business associates handling protected health information. Cloud providers that maintain electronic PHI can be business associates even when data is encrypted and they have no decryption key. Check the actual data/service role and business-associate agreement. A healthcare customer alone does not establish scope. Proposed Security Rule changes must be tracked separately from the currently effective rule.
Jurisdictions: US-FEDERAL
Research applicability questions
Are you a HIPAA covered entity, or do you create, receive, maintain or transmit PHI for a covered entity or another business associate?
Which protected health information does the service handle, and under whose business-associate agreement?
Does your service handle electronic PHI, including encrypted information for which you do not hold the decryption key?
What size, complexity, capabilities and risk factors affect implementation of your HIPAA safeguards?
For each addressable implementation specification, have you evaluated reasonableness and documented any alternative?
An emergency action plan is required when another OSHA standard triggers 29 CFR 1910.38. Confirm the triggering standard and state-plan coverage. A plan must generally be written and available to employees; employers with ten or fewer employees may communicate it orally. Do not infer a written-plan violation solely from the industry label.
Jurisdictions: US-FEDERAL
Research applicability questions
Which OSHA standard requires an emergency action plan for this workplace?
How many employees does the employer have, and does the ten-or-fewer oral-plan exception apply?
Does an OSHA-approved state plan apply, and does it impose different workplace requirements?
What work activities, hazards and other OSHA standards trigger this workplace emergency-plan duty?
Drug manufacturing current good manufacturing practice
21 CFR Parts 210 and 211
For drug manufacturing and related operations within the applicable FDA CGMP regime. Parts 210 and 211 address finished pharmaceuticals; product type and operations can require other provisions. FDA production/process Q&A is nonbinding guidance, not the complete rule. Distinguish manufacturer, contract operation and outsourcing roles before choosing checks.
Jurisdictions: US-FEDERAL
Research applicability questions
What drug product and manufacturing, packaging, testing or holding operations are performed?
Is the organization the manufacturer, contract facility or an outsourcing operation with its own applicable regime?