1989 HL7 Version 2 created to support hospital workflows

1990 The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) created

1994 Logical Observation Identifiers Names and Codes (LOINC) created to meet the demand for an electronic clinical care and management database

1995 HL7 begins work on V3 to replace V2

1999 First data standards for RCT developed by an all volunteer group (which becomes CDISC in 2000)

1999 First version of Medical Dictionary for Regulatory Activities (MedDRA) released

2000 The Clinical Data Interchange Standards Consortium (CDISC) forms an independent, non-profit, standards development organization

2003

FDA accepts electronic submission of regulatory data using ICH based Electronic Common Technical Document (eCTD)

CDISC develops new standards for labs

2004

COTS products developed to validate and analyze CDISC SDTM-formatted clinical trial data

FDA recommends use of CDISC for submission

2005 HL7’s initial standard publication of V3

2012 HL7 FHIR, developed

2014 FDA Safety and Innovation Act (FDASIA) mandates FDA implement electronic submission requirements & data standards

2016

FDA requires NDA, BLA data be submitted in CDISC format

MedDRA required for coding AEs & Medical History

2018 Framework for FDA’s Real-World Evidence Program released noting the development of data standards for RWE

2019 Multiple standards exist to support RWD/RWE

2022 Mandatory Use of eCTD v4.0: Transition to mandatory use of eCTD v4.0 for all submissions was implemented.

2024 ONC requires health information exchange networks to support HL7 FHIR standard