Standards & regulations

FGI Guidelines for Design and Construction of Hospitals

The FGI Guidelines are the de facto reference for the physical design and construction of hospital facilities in the United States. They set minimum requirements for room area, clearances, headwall configuration, plumbing, and unit organization, and are adopted by reference into many state health department codes.

Facility Guidelines Institute

WHO Guidelines for Community Noise (hospital wards)

WHO's community-noise guidelines recommend sound-level thresholds for hospital patient rooms, widely cited in acoustic-design work. Actual hospital noise routinely exceeds these levels; the guidelines set the target, not the norm.

World Health Organization

ANSI/ASHRAE/ASHE Standard 170 — Ventilation of Health Care Facilities

Standard 170 specifies minimum ventilation requirements for hospital, outpatient, and residential health-care spaces. It defines air changes per hour (ACH), pressure relationships, filtration efficiency, and temperature/humidity ranges for every functional space in a hospital, including the patient room and airborne infection isolation room.

ASHRAE

IEC 60601-1-8 — Requirements, tests and guidance for alarm systems in medical electrical equipment

60601-1-8 is the collateral safety standard that governs how audible and visual alarms behave on medical devices. It defines alarm priorities, sound characteristics, information content, and requirements for delegating and logging alarms — the reason patient monitors across vendors sound broadly similar.

International Electrotechnical Commission

IEC 60601-1 — General requirements for basic safety and essential performance

The base standard for the safety of medical electrical equipment. It defines requirements for electrical, mechanical, and thermal safety, plus the essential performance a device must retain during single-fault conditions. Every bedside device in a hospital room is certified against 60601-1 or an equivalent regional variant.

International Electrotechnical Commission

IEC 60601-2-27 — Particular requirements for ECG monitoring equipment

The particular safety and performance standard for continuous ECG monitoring devices, covering electrode configurations, arrhythmia detection performance, and lead-off detection.

International Electrotechnical Commission

ISO/IEEE 11073 — Health informatics — Point-of-care medical device communication

The 11073 family standardizes how medical devices describe themselves and their measurements. -10101 is the nomenclature (a controlled vocabulary of what a value means), and -10201/-20601 govern device communication. It is the vendor-neutral vocabulary that lets a Philips monitor and a Dräger ventilator report a heart rate the same way to an EHR.

ISO / IEEE

HL7 Fast Healthcare Interoperability Resources (FHIR) R4

FHIR is the modern REST/JSON standard for healthcare data exchange. In the US, ONC's Cures Act rule mandates FHIR R4 APIs for certified EHRs, using the USCDI dataset. FHIR is what the smart room usually speaks to the outside world after HL7 v2 speaks to the bedside.

HL7 International

HL7 Version 2 messaging standard

HL7 v2 is the pipe-and-hat delimited messaging standard that carries most bedside device and lab traffic inside hospitals today. It predates FHIR by decades and remains dominant for ADT, orders, results, and device observations.

HL7 International

United States Core Data for Interoperability

USCDI is the minimum data set that ONC-certified health IT must exchange. It defines the data classes and elements that FHIR APIs are expected to support, and is refreshed annually through a public process.

ONC (Office of the National Coordinator for Health IT)

National Early Warning Score 2

NEWS2 is a standardized aggregate score for detecting clinical deterioration in adult patients on the general ward. It is calculated from six physiological parameters plus supplemental oxygen and consciousness, and is the most widely cited early-warning score in continuous-monitoring guides.

Royal College of Physicians (UK)

Health Insurance Portability and Accountability Act — Privacy and Security Rules

HIPAA's Privacy Rule (Subpart E) governs the use and disclosure of protected health information, and its Security Rule (Subpart C) sets safeguards for electronic PHI. Together they define what can be recorded in the room, who may access it, and how it must be protected.

US Department of Health and Human Services (HHS/OCR)

NIST Special Publication 800-66 Rev. 2 — Implementing the HIPAA Security Rule

NIST's implementation guidance for the HIPAA Security Rule. It maps the Security Rule's administrative, physical, and technical safeguards to the NIST Cybersecurity Framework and provides concrete controls for covered entities.

National Institute of Standards and Technology

ISO/IEC 27701 — Privacy Information Management System

An extension to ISO/IEC 27001 that adds privacy-specific controls for organizations that process personally identifiable information. Referenced by hospitals building privacy-management programs beyond HIPAA's baseline.

ISO / IEC

IES RP-29 — Lighting for Hospitals and Health Care Facilities

RP-29 is the applications standard for lighting design in hospitals, including inpatient rooms. It defines target illuminance for exam, ambient, and night settings, plus glare, color rendering, and circadian considerations.

Illuminating Engineering Society

CDC Guidelines for Environmental Infection Control in Health-Care Facilities

The CDC's authoritative guidance on environmental controls for infection prevention in healthcare buildings. It defines ventilation, filtration, water, and construction/renovation practices to reduce healthcare-associated infections, and is the basis for AIIR requirements in the US.

US Centers for Disease Control and Prevention