SAFE-BioPharma Association

What SAFE-BioPharma Association does

SAFE-BioPharma Association is a non-profit association founded in 2006 and headquartered in Tenafly, New Jersey, that created and manages the SAFE-BioPharma® digital identity. The organization operates as a standards and trust-framework steward for the biopharmaceutical sector, issuing and governing a digital identity credential used to authenticate individuals and entities operating in regulated life-sciences workflows. Its governance of the registered SAFE-BioPharma® mark and its associated trust-framework policies constitutes the core of its functional role, distinguishing it from broader healthcare interoperability bodies.

The association is led by Scott Stuewe in the role of President and CEO. The organization is small, with 1-10 employees, consistent with a niche standards-body operating model rather than a commercial software vendor. In 2018, SAFE-BioPharma Association expanded its footprint via the acquisition of H-ISAC (the Health Information Sharing and Analysis Center), a move that extended the association's mandate from digital identity credentialing into health-sector information sharing and threat analysis.

The business model is association-based: SAFE-BioPharma generates revenue from members and stakeholders who rely on its digital identity standard for biopharmaceutical use cases, rather than from direct software licensing or transaction fees. No public pricing, membership tiers, or revenue figures are disclosed in the available input, and no parent company, subsidiaries, or external funding rounds are indicated. Customer segments are not explicitly enumerated, but the association's mission implies biopharma sponsors, contract research organizations, regulators, and clinical-trial stakeholders as the natural user base for the SAFE-BioPharma credential.

Name

SAFE-BioPharma Association

Legal name

DirectTrust

Website

https://safe-biopharma.org

Company type

Private

Founded year

2013

Operating status

Operating

Headcount range

1–10 employees

Short description

SAFE-BioPharma Association is a non-profit standards body that created and manages the SAFE-BioPharma digital identity credential for the biopharmaceutical sector, serving life-sciences organizations that require trusted digital authentication.

Ownership category

akta.pro rank

Product category

Digital Identity Services

akta.pro primary industry

Health Data Privacy, Security & Interoperability Regulators (HLAJACAE)

akta.pro secondary industry

Application & API Security for Digital Health (WAF/RASP/API gateways) (HLACAJAH)

Keywords

• Digital identity management
• Biopharma trust framework
• Identity verification services
• Credential management systems
• Healthcare identity federation

Headquarters

HQ city

Tenafly

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales

Revenue model

1. Membership Fees: Annual membership fees providing organizations access to standards influence, peer networks, advocacy, branding benefits, co-branded materials, and service discounts
2. Accreditation Services: Accreditation programs for healthcare organizations and AI systems in healthcare, including the AI Accreditation Program launched in 2026

Pricing tiers

Go-to-market motion1 record

Distribution channels3 records

Marketing channels7 records

Core offering

SAFE-BioPharma Association is a non-profit association that created and manages the SAFE-BioPharma digital identity, providing identity trust and verification services for the biopharmaceutical and healthcare research sectors. The association operates a sector-specific digital identity framework that supports verified identity assurance for organizations and individuals collaborating in regulated biopharma environments.

Product overview

DirectTrust is a non-profit organization that operates as a trust framework and standards body for healthcare data exchange. Its core offerings include Direct Secure Messaging infrastructure, Directory Services, Trust Bundles, PKI Certificate services, and Accreditation programs. The organization maintains multiple technical standards including The Direct Standard®, TIM+, Event Notifications via Direct, IX4HS, PEHRLS, and Interoperable Secure Cloud Fax. As of June 2026, DirectTrust launched an AI Accreditation Program for healthcare AI governance.

Differentiator

Problem solved

Functional benefit

Products and services

• SAFE-BioPharma Digital Identity The SAFE-BioPharma digital identity is the association's core offering, providing verified digital identity services for individuals and organizations in the biopharmaceutical and healthcare research sectors. It supports identity assurance and trust for collaboration in regulated biopharma environments.

Quantifiable outcome

• Billions of cumulative messages sent and received through the DirectTrust network
• +1 more outcomes

Named customers10 records

Segments5 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature9 records

Partnerships

17 partnerships are on record, tiered core and flagship.

• Trans SpedcoreTechnology or IntegrationRomanian eID qualified trust service provider and member of DirectTrust contributing to standards development and PKI trust framework
• U.S. Department of Health and Human ServicescoreStrategic or Co-development PartnerFederal health agency partner participating in DirectTrust standards and trust framework for national health data exchange
• U.S. Department of Veterans AffairscoreStrategic or Co-development PartnerFederal agency partner using Direct standards for veterans healthcare data exchange and interoperability
• United Health GroupcoreStrategic or Co-development PartnerMajor health payer and technology company participating in DirectTrust for health plan data exchange standards
• athenaHealthcoreTechnology or IntegrationEHR vendor integrating Direct messaging into cloud-based healthcare management solutions
• Oracle HealthcoreTechnology or IntegrationMajor EHR platform integrating Direct standards for secure health information exchange
• CommonWell Health AlliancecoreStrategic or Co-development PartnerHealth information network alliance providing nationwide interoperability services alongside DirectTrust
• Civitas Networks for HealthcoreStrategic or Co-development PartnerNational network of health information exchanges collaborating on standards and interoperability
• HIMSSflagshipGTM or Marketing PartnerStrategic partnership for annual conference presence and joint marketing at healthcare IT's largest industry event
• The Sequoia ProjectcoreStrategic or Co-development PartnerCollaboration on interoperability initiatives including the Data Usability Workgroup for healthcare data standards
• HITRUSTcoreStrategic or Co-development PartnerSecurity framework partnership for healthcare information protection and compliance alignment
• DigiCertcoreTechnology or IntegrationCertificate authority providing PKI certificates for DirectTrust identity verification and trust framework
• AvailitycoreTechnology or IntegrationHealth information network and revenue cycle management platform integrating Direct messaging
• SurescriptscoreTechnology or IntegrationHealth information services network integrating Direct standards for prescription and clinical information exchange
• eClinicalWorkscoreTechnology or IntegrationEHR vendor integrating Direct messaging for practice management and interoperability
• NextGen HealthcarecoreTechnology or IntegrationEHR and practice management vendor integrating Direct standards for secure messaging
• Consensus Cloud SolutionscoreTechnology or IntegrationCloud fax and document exchange provider integrating with DirectTrust for interoperability

Scale indicators4 records

Recent moves1 record

Expansion highlights1 record

Broad incumbents

• HIMSS: Largest healthcare IT industry association and global conference operator. DirectTrust partners with HIMSS for conference presence and visibility; comparable as an industry-wide standards and advocacy body for healthcare IT, but with a far broader remit than interoperability.

Direct peers

• MedAllies: DirectTrust-Accredited HISP providing Direct Secure Messaging for clinical data exchange. A smaller-scale, more focused operational peer operating within DirectTrust's trust framework.
• HITRUST: Security and privacy compliance framework for healthcare. DirectTrust explicitly partners with HITRUST to bridge accreditation and certification; both issue healthcare-specific assurance credentials and operate as non-profit governance bodies.
• eHealth Exchange: National health information network operated by The Sequoia Project connecting federal agencies (including VA) and providers. Overlaps with DirectTrust on large-scale trusted health data exchange infrastructure and federal agency participation.
• Health Level Seven International (HL7): Standards development organization behind FHIR and other healthcare interoperability specifications. Comparable as the foundational SDO for clinical data exchange; competes/coexists with Direct Standard for provider-to-provider messaging.
• CommonWell Health Alliance: Health information network alliance providing nationwide interoperability services. DirectTrust lists CommonWell as a contributing member; both operate competing/complementary nationwide HIE networks enabling cross-organization record exchange.
• The Sequoia Project: Non-profit public-private collaborative that operates the eHealth Exchange and other interoperability initiatives, collaborating with DirectTrust on healthcare data exchange standards. Both operate as ANSI/standards-aligned non-profit trust frameworks for health information sharing.
• CAQH CORE: Operating rules authority for administrative healthcare data exchange between providers and payers. Comparable as a non-profit governance entity that codifies interoperability standards used across the US healthcare ecosystem.
• NATE (National Association for Trusted Exchange): Non-profit fostering trusted exchange among HIEs and providers. Operates in the overlapping identity/trust framework space as DirectTrust, including patient-centered data exchange initiatives.

Emerging players

• CARIN Alliance: Multi-stakeholder collaborative advancing consumer-directed health data exchange using APIs (FHIR). Complementary/competing to Direct messaging, focused on patient-facing exchange rather than provider-provider messaging.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat2 records

Customer concentration

• LinkedInlinkedin.com/company/directtrust
• Xx.com/safe_biopharma

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about SAFE-BioPharma Association