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What is SAFE
Identity?

SAFE Identity is an industry consortium and certification body supporting identity assurance and cryptography in healthcare to enable trust, security and user convenience.

The Healthcare Industry Has a Digital Trust Problem

The risk and uncertainty associated with identity in virtual clinical trials, telehealth, medical devices, and sensitive data exchange in healthcare supply chains makes trust a complex problem for healthcare providers.
Sensitive healthcare data requires high levels of security and assurance – but the integrity of and confidence in identity assertions vary widely across the health industry. Even when we standardize on digital credentials, the question remains: Which digital identity issuers can healthcare providers trust?

Answer
Rely on SAFE Identity

SAFE Identity establishes the criteria by which digital identity issuers demonstrate the integrity of their digital credentials. SAFE Identity certification provides assurance to the healthcare community that a specific digital identity credential meets the SAFE Identity standards.

These SAFE Identity Certified Credential Providers are complemented by a list of tested and certified products that further facilitate trust and interoperability between members of the healthcare community. In effect, the healthcare community trusts a single entity: SAFE Identity.

Protect trade secrets and confidential information

Secure login to avoid compromise and data breaches

Securely identify medical devices within the network

Federate identities across multiple organizations

Securely exchange data in global supply chains

Identify individuals for confidential PII access

Secure signatures for research documents or patient files

Strongly identify patients for virtual clinical trials

Benefits of Participating in the
SAFE Identity Global Ecosystem

The SAFE Identity global ecosystem leverages the work done by SAFE Identity to ensure the security, global interoperability, user convenience and trusted data exchange between healthcare participants.

Signatures

Have confidence in the identity of who signed the document and the integrity of its contents, ensuring protection against unauthorized changes.

Authentication

Be assured the individuals you’re doing business with are who they present themselves to be.

Federation

Manage your trusted identities within a network of like-minded providers committed to the power of shared standards, policies and practices.

Encryption

Know the information you share via the internet is accessible only to the intended recipients.

Stakeholders in the
SAFE Identity Global Ecosystem

Relying Parties

Organizations that depend on and require SAFE Certified Credentials for conducting business in cyberspace.

Asserting Parties

Organizations and partners, subcontractors and patients who use SAFE Certified Credentials to secure digital interactions.

Bridge CA

Bridge certification authority that federates interoperability and trust across the SAFE Identity global ecosystem.

Technology Providers

Developers of applications and cloud services approved by SAFE Identity for use within the SAFE Identity global ecosystem.

Credential Providers

SAFE Certified organizations that offer digital credentials to Asserting Parties.

The FDA

SAFE Certified Credentials are accepted digital signatures for regulatory trial submissions and other data exchanges.

Enabling the
Ecosystem

The SAFE Identity global ecosystem is governed by the Policy Management Authority (PMA), a committee of leading technology and healthcare providers, who define the policies needed to create and use globally interoperable digital identity credentials. SAFE Identity leverages 15 years of experience in digital identity issuer certification to ensure to ensure that today’s SAFE Certified Credential Providers are indeed providing the required operational integrity in accordance with the policies established by the PMA. The ecosystem is backed by industry healthcare technology leaders including AstraZeneca, Astellas, GSK, Gilead, IdenTrust, Exostar, Trans Sped and H-ISAC.

To further serve the community, SAFE Identity offers a suite of services that include

Lab testing and certification of applications along with a published list of these qualified products

A bridge certificate authority to facilitate trust and interoperability between multiple credential issuers

A global lookup directory of qualified organizations and individuals to enable encryption across the SAFE Identity ecosystem.

Learn More About SAFE Identity


Healthcare
Organization

RELY ON SAFE >

Identity
Provider

CERTIFY >

Technology
Provider

CERTIFY >

Request Policies and Standards

SAFE PMA >

Frequently Asked Questions

Relying party companies with supply chains distributed across the country and across the world can rely on the SAFE Identity Trust Framework for free to confidently verify the identity of individuals who they have never met and have no HR process with. The SAFE Identity Trust Framework is a secure, enforceable, and regulatory-compliant way to verify and manage internal and external identities of parties involved in electronic transactions. The SAFE Identity Trust Framework also provides a convenient way to apply legally-binding digital signatures to electronic documents. With each signature, the identity of the signer is clearly verified and the integrity of the document is cryptographically guaranteed. Regulatory agencies recognize and can audit digital signatures generated using SAFE Identity certified credentials.

Its growing use in Electronic Laboratory Notebooks and other applications assures protection of intellectual property and strong evidence in legal proceedings around patent disputes.

Yes. Electronic documents signed using SAFE Identity certified credentials signatures are accepted by the FDA. They also meet the highest legal equivalent of handwritten signatures for mutual recognition across the European Union and the European Economic Area. SAFE Identity credential providers who also have achieved a Qualified CA status can also offer credentials that may be used for digital signatures in business and regulatory transactions across Europe with confidence that they meet the strict EU and Member State requirements for legal digital signatures.

Health companies who purchase SAFE Certified credentials are using the SAFE Identity Trust Framework in ways that achieve numerous goals including streamlining processes, protecting intellectual property and reducing costs. The standard is a convenient way to apply legally-binding digital signatures to electronic documents, log into applications and encryption data between companies around the world. When using SAFE Identity certified credentials for signing, the identity of the signer is clearly verified and the integrity of each digitally signed document is cryptographically guaranteed. SAFE Identity digital signatures are being used to sign electronic laboratory notebooks, electronic regulatory submissions, contracts and a wide variety of forms. Relying party companies may also use SAFE Identity for a variety of identity management functions including employee access, external partner authentication, and email encryption between partners, among many others.

SAFE Identity is a global, interoperable digital identity infrastructure for use across the health industry. As a standard developed by health industry participants, SAFE Identity is technology and vendor-neutral and avoids the complexity of dealing with multiple digital identity providers across multiple trust networks. SAFE Identity also works closely with regulatory agencies to ensure they understand and accept SAFE Identity digital identities.

The SAFE Identity Trust Framework is a set of community-driven policies that set rules around how people and devices obtain a digital identity. These rules are publicly available in our Certificate Policy and the Trust Framework is free for anyone to Rely on Us for verifying digital identities certified under the SAFE Identity Trust Framework.

The purpose of the SAFE Identity Qualified Products List is to ensure:

  1. That all applications certified by SAFE Identity are interoperable with credentials from any one of the SAFE certified identity providers, and;
  2. Ensures conformance with cryptographic industry best practices.

The SAFE Identity Qualified Products List (QPL) is a list of certified identity software products that have been tested in the SAFE Identity QPL lab. SAFE Identity maintains a suite of technical specifications that outlines the ways applications must use digital identities for digital signatures, logging into applications and encrypting information. In order to be listed on the SAFE Identity QPL, a software vendor must install their software in our lab and pass all of the required tests outlined in our technical specifications. Software that successfully passed all of our tests is listed on the SAFE Identity QPL along with with a description of the product, version of the product, the specific configurations of the product and the specification version the product was tested against.

The SAFE Identity Trust Framework provides users with a secure, enforceable, and regulatory compliant way to verify identities of parties involved in electronic transactions using their digital identities to digitally sign documents, log into applications and encrypt information across companies and across the world.

Digital signatures applied using SAFE Identity Certified Credentials are legally binding and help eliminate the need for paper-based business processes and paper backup copies. Individuals who are credentialed via processes compliant with the SAFE Identity Trust Framework have had their identity verified in a strongly trusted manner. When they digitally sign documents using any of the approaches that are compliant with our policies, the identity of the signer is clearly verified and the integrity of the document is cryptographically guaranteed.

The growing culture of collaboration within the pharmaceutical and healthcare industries requires working with a broad community of resources — each constituting its own island of information. Standardizing the way identity is determined and how they are used by applications is possibly the single most important change that will allow the many information islands to communicate efficiently and with trust. Together, the SAFE Identity Trust Framework and QPL provide a secure, enforceable, and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions.

The SAFE Identity Trust Framework provides users with a secure, enforceable, and regulatory compliant way to verify identities of parties involved in electronic transactions using their digital identities to digitally sign documents, log into applications and encrypt information across companies and across the world.

The SAFE Identity Trust Framework allows secure and trusted information exchange within a growing global network comprising many different entities with many different information systems. This network includes partners, vendors, supply chain participants and government agencies such as the FDA, Health and Human Services, Department of Defense, Homeland Security, US Patent and Trademark Office and others. The SAFE Identity Trust Framework is the first network of trust between companies with the health industry and Federal agencies. The SAFE Identity network is open to both enterprise and commercial issuers including IdenTrust, Exostar, and Trans Sped.

Rely on the SAFE Trust Framework

The integrity of digital credentials varies widely from one provider to the next. Figuring out who to trust, why to trust them and how their security aligns with your needs can be a challenge. This makes trust hard.

The SAFE Identity Trust Framework, carefully cultivated over 15 years, can make trust much easier. The Trust Framework defines the policies and standards necessary to use secure and interoperable digital credentials that meet your needs. Issuers certified by SAFE are compliant with these policies and standards, ensuring this same security and interoperability across the ecosystem – and making trust a lot simpler for you.

Are you ready to consider your next steps

RELY ON SAFE


Get in touch with
SAFE Identity

...
Address

1900 Reston Metro Plaza,
Suite 303, Reston, VA 20190

Email

info@makeidentitysafe.com

Phone

703.705.2920