Standards & regulations

FGI Code for Planning and Design of Hospitals (formerly 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. Medical electrical equipment at the bedside is typically evaluated against 60601-1 or a regional adoption of it.

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

IEC 80001-1:2021 — Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

IEC 80001-1 is written for the organization that connects things, not the manufacturer that builds them. It sets general requirements for a healthcare delivery organization to apply risk management before, during, and after a health IT system — including connected medical devices and health software — is connected to its health IT infrastructure, addressing three key properties: safety, effectiveness, and security. The 2021 second edition replaced the 2010 first edition, restructured the standard to align with ISO 31000, and placed the requirements on the organization.

International Electrotechnical Commission (IEC), published jointly with ISO (ISO/TC 215)

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

IHE Devices — Alert Communication Management (ACM) Integration Profile

ACM is an IHE integration profile for getting an alert — a physiological or technical alarm, or an advisory such as a workflow event — from a patient care device or system to a person's communication device, and reporting back what happened. An Alert Reporter sends the alert to an Alert Manager over HL7 v2; the Alert Manager decides who should receive it and on which device, and hands it to an Alert Communicator over WCTP; delivery status, read receipts, and operator responses flow back. The profile was previously named Alarm Communication Management and was renamed to cover advisories as well as alarms.

IHE International — Devices (DEV) domain, formed as Patient Care Device (PCD)

IHE Devices — Device Enterprise Communication (DEC) Integration Profile

DEC is the IHE profile for publishing point-of-care device data — from vital signs monitors, infusion pumps, ventilators, anesthesia systems, and similar devices — to enterprise applications such as clinical information systems and EHRs. A Device Observation Reporter, typically a gateway, device, or clinical information system, maps proprietary device data into a single syntactic and semantic representation, time-stamps it with consistent enterprise time, and sends it to a Device Observation Consumer as an HL7 v2 message. The ACM alert profile extends DEC.

IHE International — Devices (DEV) domain, formed as Patient Care Device (PCD)

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 has been updated through an annual 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

A privacy information management system (PIMS) standard with requirements and guidance for organizations acting as PII controllers or processors. The 2019 edition was an extension to ISO/IEC 27001; the 2025 edition is a standalone management-system standard that can still be integrated with 27001. Referenced by hospitals building privacy-management programs beyond HIPAA's baseline.

ISO / IEC

ANSI/IES RP-29 — Recommended Practice: Lighting Hospital and Healthcare 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

NFPA 99 — Health Care Facilities Code

NFPA 99 establishes criteria for levels of health care services or systems based on risk to patients, staff, or visitors, to minimize the hazards of fire, explosion, and electricity. Instead of keying requirements to the type of building, it applies them according to a documented risk assessment of what happens if a system fails. In the patient room it is the code behind medical gas and vacuum outlets, electrical systems and power continuity, electrical and gas equipment, and — in its information technology and communications chapter — nurse call.

National Fire Protection Association (NFPA)

ANSI/UL 1069 — Standard for Hospital Signaling and Nurse Call Equipment

UL 1069 is the US safety standard for the individual units and equipment that make up a fundamental hospital signaling nurse call system (NCS). Its scope defines a fundamental NCS as providing audible and visual communication between patients and staff, conforming to the minimum requirements of the Health Care Facilities Code (NFPA 99) and the National Electrical Code (NFPA 70). It is the reason the core call path — pull, annunciate, dome light, reset — is evaluated as a safety function rather than a convenience feature.

UL Standards & Engagement