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HLS regulators TeamSync supports.
The map below shows the regulators most relevant to HLS deployments and the rules / standards each enforces. For each, the relevant TeamSync overlay is linked.
For per-regulator evidence packs, contact an HLS solutions engineer .
Drug + biologic + device authorities.
Regulator
Scope
Relevant overlays
FDA (US)Drugs, biologics, devices, food
21 CFR Part 11 + 21 CFR 312 + 314 + 600 + 803 + 820
EMA (EU)EU centralised authorisation
EU GMP Annex 11; EU CTR 536/2014
MHRA (UK)UK post-Brexit medicines + devices
UK GMP + GCP; UK CTR transition
PMDA (Japan)Japanese pharma + device
J-GMP + ICH-aligned
NMPA (China)China pharma + device
NMPA framework
Health Canada Canadian pharma + device
Canadian GMP (Division 2)
TGA (Australia)Australian pharma + device
TGA GMP
ANVISA (Brazil)Brazilian pharma + device
RDC frameworks
Privacy + healthcare-data authorities.
Regulator
Scope
Relevant overlays
HHS OCR (US)HIPAA enforcement
HIPAA
ICO (UK)UK GDPR + DPA 2018
UK GDPR / ICO guidance
EDPB + national DPAs (EU)EU GDPR
GDPR Art. 17
CDSCO + DPDP authority (India)India healthcare data
DPDP Act
Standards bodies + accreditation.
Body
Scope
Relevant alignment
ICH International harmonisation
E6(R3), E2A/B, Q-series
CDISC Clinical data standards
CDISC-aligned
DIA Drug information association
TMF Reference Model
The Joint Commission US hospital accreditation
Information management
NCQA US health-plan accreditation
HEDIS measures
HITRUST Healthcare-extended security
CSF
AI-specific regulator activity.
Body
Scope
Relevant overlay
FDA AI/ML SaMD Software-as-medical-device with AI
Algorithm change protocol
EU AI Act High-risk healthcare AI
EU AI Act
ONC HTI-1 US algorithmic transparency
Per-feature documentation
CHAI Coalition for Health AI assurance standards
Industry alignment
Per-regulator evidence packs.
For each regulator above, TeamSync can generate an evidence pack mapping the customer's deployment to the regulator's specific control / rule expectations.
