Trustworthy Healthcare Ecosystem

Full Title

Examine the healthcare ecosystem from the perspective of a patient of that system.

Goals

1. Profile of IDEF (Trusted Identifiers in Cyberspace) for healthcare industry in US.
2. Sandbox to test IDEF compliant web sites and mobile applications with healthcare as the first test case.
   1. Testing must include all 4 IDEF components of: Security, Privacy, User Experience and Interoperability.

Context

• The wiki page Health Care Profile establishes the context for this page.
• For a healthcare trust ecosystem to have value for a patient, these criteria are important:

1. The patient can know that their medical and other records are safe within any provider's Electronic Health Record (EHR) database.
2. The user can determine the trustworthiness of other providers that are seeking access to their medical and other records.
3. Trust begins when a doctor sees a patient for the first time with a current complaint. The patient provides some identification and subjective information about their history and health problem and then the doctor does an objective (clinical ) exam which may or may not validate the initial complaint. That is the start of a trust relationship.
4. After the patient has visited a PCP (Primary Care Physician) they are entitled to acquire their medical records. Where the records are stored digitally, the patient must be give online access.

• TEFCA says that if the patient has a trusted identity the patient should be able to view any episode of medical care, as reflected in their medical record, online and be able to download it and and share it with others. In those cases trust must be established and shared within the ecosystem by digital means. (See reference at bottom of page.)

Real World Entities

• The patient, their family, other support personnel, suppliers of equipment and the physical places where the patient goes are all legal entities and have legal obligations.

1. Patient - is the person receiving care and the one that "owns" the rights to the information.
2. Non-Covered Entities - Guardians, Delegated Authorities, Lawyers, etc. may act for the patient or just be others that the patient trusts to receive their medical records. The access can be conditional or date-time sensitive.
3. Covered Entities - Any entity that is covered by HIPAA rules including the places that a patient goes for medical care. They will all be recognized as such in the digital world by virtue of trust certificates. Some of these will perform Identity Proofing. The digital services that they provide are listed below.
4. Suppliers of medical equipment, including internet connected equipment and software may need to be checked for compliance and trust prior to use by the patient. For the purposes of this document, all hardware and software that deals with PHI is considered to be medical equipment and software that needs to be compliance tested. This requirement likely goes beyond a strict reading of the HIPAA security requirements.
5. Patient Support - is source of the user connected devices (phone or computer) and the code running on the user's device. The device with the attested application code is trusted to protect the patient's credentials and medical records from disclosure. (See the section Native Apps to hold the Patient PHI below for a discussion of some of these points.

User Digital Devices

This section deals with users which might be the patient or someone acting on behalf of the patient. The manner that a person gets the right to act on the patient's behalf is beyond the scope of this document and may vary from state to state.

• The user has the right to access the patient's Electronic Health Record (EHR) database from their digital device. (See TEFCA below)
• The exact form that the user can receive the data is not specified.
• The exact nature of "secure access" to the information is not not specified.
• There are multiple ways to provide the information and to secure access, none has been acceptable to all of the participants. See solutions below.
• The Cures Act Final rule focuses on the prevention of Information Blocking by allowing user access to APIs, but does allow the EHR to validate the App developer. The companion wiki on Trustworthy Healthcare Applications is an attempt to take the limited ONC Guidance into a set of guidelines that can be used to create a set of Software Assessment Criteria for use by an Accreditation Authority and their credentials validators in assessment of developers and applications.

Digital Service Endpoints

• These services may be combined on Web Sites in any way that works for the participants. These services all expose a common set of API's based on FHIR, but extended to allow online verification of trust and patient authentication information to be exchanged before data flows.
• While there may be distinct services that are available at each endpoint, there will (nearly) always be multiple endpoint at one particular domain named service. The domain named service is most often available as a result of a DNS entry for the host name such as https://example.com. Which must responds to requests for metadata that describes it in well-known protocols and semantics.
• These domain names and endpoints all belong to a single legal entity which is a member of the appropriate federation where the metadata may be examined.
• The issue of Trustworthy Healthcare Providers is important for flows not only among members of the federation, but also among also flows to and from the patients and their guardians. Please see that wiki page for more details about the identification of Trustworthy Healthcare Providers.

1. Trust Registry - is an online Trust Anchor for information about medical providers that have met the appropriate operational criteria. All of the following endpoints will have trust certificates from a trust registry.
2. Credential Service Provider - is the glue between the user devices and the Covered Entities that perform identity proofing. It provides IAL2/AAL2 evidence that an App can act as the agent for the patient.
3. Trusted Third Parties authenticate the patient or others with legitimate access to patient medical records.
4. EHR - the Electronic Health Record is required to respond to legitimate requests in a timely manner. It may also participate in patient matching. (See the HHS Primary Care Patients Use Interactive Preventive Health Record Integrated With Electronic Health Record, Leading to Enhanced Provision of Preventive Services) The EHR must release information to the patient with proper IAL2 authentication. Access by other individuals to the EHR is subject to local as well as federal regulation.
5. Payment Provider - can a part of both the patient proofing and patient authentication processes in most practices. At least one service will list covered solutions and indicate if the patient has co-pays that they need to make. This class of service endpoint also includes payment sources, like credit cards.
6. Medical Record Locator Service - is a source for the patient or trusted providers to search for records about the patient. It has yet to be fully specified, but is assumed to exist.

Legally Mandated Access

US Federal Regulations (CFRs) place burdens on the covered medical entities to provided PHI to the patient (or legal guardian). Individuals’ Right under HIPAA to Access their Health Information 45 CFR § 164.524 are filled with dense descriptions that are meant to clarify the obligations of the medical entity, but do not mention trust in any form. They do describe verification in these terms:

The Privacy Rule requires a covered entity to take reasonable steps to verify the identity of an individual making a request for access. See 45 CFR 164.514(h). The Rule does not mandate any particular form of verification (such as obtaining a copy of a driver’s license), but rather generally leaves the type and manner of the verification to the discretion and professional judgment of the covered entity, provided the verification processes and measures do not create barriers to or unreasonably delay the individual from obtaining access to her PHI, as described below. Verification may be done orally or in writing and, in many cases, the type of verification may depend on how the individual is requesting and/or receiving access – whether in person, by phone (if permitted by the covered entity), by faxing or e-mailing the request on the covered entity’s supplied form, by secure web portal, or by other means. For example, if the covered entity requires that access requests be made on its own supplied form, the form could ask for basic information about the individual that would enable the covered entity to verify that the person requesting access is the subject of the information requested or is the individual’s personal representative. For those covered entities providing individuals with access to their PHI through web portals, those portals should already be set up with appropriate authentication controls, as required by 45 CFR 164.312(d) of the HIPAA Security Rule, to ensure that the person seeking access is the individual or the individual’s personal representative.

These are the HIPAA security rules that are relevant to this page. (Note that it is not likely that HIPAA security rules apply to data once it has been release to the patient, but that concern is important to privacy and to a good user experience.):

(d)Standard: Person or entity authentication. Implement procedures to verify that a person or entity seeking access to electronic protected health information is the one claimed.
(e)
 (1)Standard: Transmission security. Implement technical security measures to guard against unauthorized access to electronic protected health information that is being transmitted over an electronic communications network.
 (2)Implementation specifications:
  (i)Integrity controls (Addressable). Implement security measures to ensure that electronically transmitted electronic protected health information is not improperly modified without detection until disposed of.
  (ii)Encryption (Addressable). Implement a mechanism to encrypt electronic protected health information whenever deemed appropriate.

TEFCA seeks to help elucidate these rules. See the reference at the bottom of this page.

Problems

• If a PCP (Private Care Practice) is the source of Identity Proofing to be used with other providers, can we provide the standards that would relieve them of liability for misuse?
• For IAL2 some means of protecting the patient authentication credentials must be available, e.g. FIDO U2F (Web Authentication) or the smart phone (with a trusted execution environment) itself.
• Medical records can apply to both state and transaction records.
  • When the patient asks for records they have the right to get everything that is permitted by law.
  • When a physician makes a referral they typical send the relevant information relating to that condition (with patient consent).
• The following problem areas were identified at the CARIN Health Care Digital ID Summit 2019-06-04. In order to best proceed the definitions have been amended slightly to make the terms into distinct entries in a Trustworthy Healthcare Ecosystem taxonomy of Identification.

1. Identity - is the matching of the real live biological human to the records necessary for billing and patient care. The level of identity proofing that occurs here will be situationally determined as would be the case (e.g.) for new versus returning patients. It will only be established by patient-present use cases, except in some low volume use cases.
2. Authentication - is the matching of the user of a digital computer system to the patient identified in problem 1. Our scope in this ecosystem is limited to the digital exchange of credentials and trust statements over the web.
3. Trust and Federation - is the trust between different organizations in different federations as well as trust of the patient for the web sites that they visit.
4. Consent - is required for all information-sharing events. In some cases blanket consent has been provided. In some venues consent has a limited life time.
5. Matching of the Patient - to their electronic health records can occur in both patient-present and remote access use cases. Prior to the time of patient matching, Identity (problem 1) and Authentication (problem 2) must have been completed. (But note that matching an incoming patient to the medical records may be included as a part of the Identity and Authentication solutions.) The most severe matching problems, when the patient is non-responsive, are out of scope here. The most common use case is presumed to be the passing of medical records from the PCP to some other provider and back again as modified.

Solutions

Relational Trust

The definition of (relational) trust is to believe in the honesty and reliability of someone or an entity you have known over time, made a good faith effort to live up to an agreement to fulfill their commitment, be it a contract or handshake agreement. ‘Trust’ is a transnational catalyst, the chemistry that initiates an interaction and reaction if not abused. (So that the trust expressed as "known to the practice" can be transmitted to other participants.)

Online Trust

Trust in this meaning is about (1) the trust of one digital endpoint for another digital endpoint, (2) the trust on one digital endpoint that the online request for PHI is authentically from the patient (or authorized guardian), or (3) the trust of the patient that a site requesting PHI is a registered covered medical entity.

• All online service endpoints shall be equipped with capability metadata that informs communications partners as to the services offered.
• All online service endpoints shall supply certificates that can be verified to prove compliance with minimal health industry standards.
• All compliant services that authenticate patients with IAL2/AAL2 will supply patient credentials as requested by other compliant medical providers.
• All services that authenticate patients will make their own determination as to the patient's identity. Patient credentials are just one component of that trust process.

Certifications today are found for:

• Certified Health IT Products List (CHPL) for software packages that can support EHR.

Patient Consent

• We need to be able to capture the patient consent in a digital message and transfer that to another provider.
  • A taxonomy for how to represent the information requirements and risks to the patient must be in use by all providers.
  • Existing taxonomies of data types in the EHR is too technical to allow patients to make informed decisions.
• The Patient must understands what information they have consented to share and what the risks to the patient are.
  • Also why the information is required to provide that care. (Transparency)
• When medical records come from the patient that consent would also be captured and given to the new provider.
  • We need the ability to create a consent receipt for moving medical records from one provider to another provider.

Bindings

• In a digital world binding are formalized with a cryptographic key signing a document that associates one entity with a collection of keys and attributes. For example the X.509 certificate.
• For the organization the trust anchor (described in federation below) works.
• For the patient some sort of private credentials are required for a formalized binding process. If the patient's credentials are well protected they can be used with an authentication protocol to prove that the patient is present for an on-line interaction.
• The binding is then between the patient and the protected key pair. The public part of the key pair is, in effect, an identifier of the patient.
• Bindings can be used to assure that any part of the system remains in the state that was known to be secure. For example, software should have a way to let any communicating party know who is controlling the interaction. Devices should all be able to make a secure statement about itself. It is also desirable for an instance of an app on a device to have a unique and secure identifier. This instance represents the life-cycle of that software on that device, not just the running instance at a moment in time. Even more trivially, each communication session should be conducted over HTTPS which will also be bound to the key that was used in interchanging secure messages.
• Note that the patient may be considered to be bound to their medical records, but that is an organizational relationship that is core to the patient matching problem. While it is not feasible for a medical record to have an identifier (index key) that is itself cryptographically bound to the patient given current US law, it is possible to include cryptographically bound identifiers in the medical record.
• The user agent will typically also create a binding between the subject and any service provider indicated the consent granted by the subject to the provider. In most cases the subject will have the ability to dissolve the binding and withdraw the consent. Contract law may override this ability to withdraw consent in some cases.

Protection of the Patient Credentials

These are the requirements from NIST SP 800-63-3.

• Identity Assurance Level 2 requires the real-world existence of the claimed identity and verifies that the applicant is appropriately associated with this real-world identity. IAL2 introduces the need for identity proofing. Since many covered entities already perform identity proofing, the remaining problem is to move that proof from the covered entity into the patient credential on the smart phone.
• Authenticator Assurance Level 2 provides high confidence that the claimant controls authenticator(s) bound to the subscriber’s account. Proof of possession and control of two different authentication factors is required through secure authentication protocol(s) e.g. FIDO U2F (Web Authentication)or Client to Authentication Protocol (CTAP FIDO?) with the smart phone (with a trusted execution environment) itself.

The wiki page Phone as Health Care Credential describes how these requirements can be met in a patient-friendly manner.

Use of Native Apps to hold the patient's PHI

While there may be multiple ways to protect patient's PHI while in the user's possession, this paper explores two use cases.

1. The app is considered to be a HIPAA covered entity and will only accept and disburse patient data to other covered entities. Exfiltration of data from this Trustworthy Healthcare Ecosystem is severely restricted, but still possible. This case is explored on the wiki page Phone as Health Care Credential.
2. The app is not a HIPAA covered entity and is not bound by the federal regulations that apply to covered entities. Apps with little regard for the patient's information may be able to convince users to share data which is not covered. The Cures Act Final Rule (2020-05-01) still requires such an app to be from a certified developer.

The above addresses information that starts out covered by HIPAA. Other data that is not initially covered includes in-home telemetry data and user entered data include patient approved medical directives.

App as HIPAA covered entity

There are severe federal penalties for exposing covered data.

• The app must be approved by a trusted authority to even open a communications channel to an EHR.
• This applies to downloading data from the EHR, as well as uploading it to other sites.
• Potentially exfiltration of data from the domain of HIPAA covered entities could be down WITH EXPLICIT APPROVAL by the user of the app.
• Rules of consent to release data could be rigorously enforced and violator could be thrown out of the federation. All federation access would be verfied for every connection to any other federated entity.

Smartphone Apps

Currently only regular FTC protections exists for user private information apply.

• There is an effort to create a "Code of Conduct" for apps that can acquire PHI from an EHR that is in development by the CARIN alliance.
• It is not clear that if a large company, like Apple, created a Health app, would then decide not to agree to the code of conduct. Could they be excluded from access PHI given the access rules of the ONC?
• While there is a code of conduct proposed by the CARIN alliance, it has not yet been declared mandatory.
• The solution for good, trustworthy Patient Choice is to bring the Smartphone apps into compliance with HIPAA if we really want patient data to be protected.

Recovery and Redress

1. Lost phone (and the use of use biometric factors to mitigate loss.)
2. Phone hijacking (aka SIM card swapping)
3. Phone migration and the related issue,
4. Access from more than one digital device.

Access Codes

The access codes are created with the permission (consent) of the Patient or the Physician. Each grants access to a limited set of data.

• Patient Credential access code provides access to the identify proofing evidence created by a Covered Entity.
• Medical Records (EHR) access code provides access to a particular patient EHR or a subset of the data in an EHR.

Biometric Factors

• Finger print
• Palm print
• Iris scan
• Face scan - particularly dynamic scans where the patient must rotate the head in response to commands from the authenticator.
• Behavior

Knowledge Authentication Factors (from KBA)

• Medical records have information that can be used to assure that the patient is correctly identified and that the patient is matched to the correct record. Clearly there are privacy concerns that must be met if this method is to be acceptable to the patient.

Federated Trust

• In a federated system there will be at least one trust anchor that provide trust certificates to the members of the federation.
• Trust Framework Membership Validation describes the API to establish trust among covered entities and for the benefit of the patient.
• Pre Oauth Entity Trust describes a means to represent third-party application endorsement for health care applications. POET’s goal is to help consumers distinguish between applications that have an endorsement versus applications that have no pedigree (i.e untrusted and could be malicious).

Record Matching

No patient is fully trusted when approaching the receptionist or any health care provider beyond the personal physician. The essential problem is that mistakes happen in health care and the wrong records get attached to the wrong human being. This can cause disastrous consequences. Ensuring that the provider that is immediately attending to the patient have relevant information about the patient is essential to good outcomes.

Next Steps

The order and extent of these items is currently arbitrary and pending review by industry experts.

1. Approve broad plan for proceeding including sources of funding.
2. Create a Patient experience set of use cases to be tested (as a part of a broader conformance verification)
3. Establish a specific plan for the sand box. (roughly to build components that correspond to the labels in the diagram above.)
4. Build a trust registry that can hold configuration/manifest data and respond to API requests for:
   1. Applications that are in conformance with Evolving CARIN best practices
   2. Trusted Provider sites with EHR - deploy at least two for the sandbox to allow a sender (e.g. a PCP) and a receiver (e.g. a specialist) for testing.
5. Build a demo native app that can show how how a patient can acquire and use an app of their own choosing with authorization code generated by PCP
6. Enlist an existing medical software vendor to build a demo app that can show how a patient can acquire and use an app from a PCP
7. Create a trusted third party web site that can:
   1. Demonstrate how a patient can enter and manage their (e.g.) emergency contact information that is entirely under their own control.
   2. Demonstrate Identification and Attribute Provider (IAP) with IAL2 authentication capability

References

Internal References

On Kantara wiki pages.

• The charter of the Kantara work group effort
• The wiki page Health Care Profile establishes the context for this page.
• Phone as Health Care Credential
• Emergency Contact Information Use Case
• Health Care Profile Sandbox
• Health IT Record Location Service (Data Aggregation)
• Patient authenticates to EHR to access their lab results
• Patient pull of information
• Patient Registration with Distributed Attributes
• Patient uses Trusted Third Party to authenticate and move EHR
• Patient with Lab and Referral Use Case
• Trust Framework Membership Validation describes the API to establish trust
• Consent to Create Binding describes the api message to be sent by the user device to the Credential Service Provider
• Trustworthy Healthcare Ecosystem (this document)

External References

• A comprehensive report on OpenID HEART which uses Kantara UMA and federated authorization.
• Heart Specs at the OpenID foundation.
• Best Practice in HealthCare
• Compliant Implementation of Trust Registry
• Electronic Health Records - EHR
• FHIR (Fast Health Interoperability Resources) is designed to enable information exchange to support the provision of healthcare in a wide variety of settings.
• FirstNet
• Health Care Digital Identity
• Health Care Identity Management
• Health Care Native App Example
• Medical Records Identifier
• Patient Experience
• Patient Health Information - PHI
• TEFCA, Trusted Exchange Framework and Common Agreement for an FHIR interaction with the transfer of PHI between Secure Nodes

The TEF Draft 2 supports the Cures Act’s goal of advancing nationwide interoperability and is a key component of HHS’ and the Administration’s broader strategy to facilitate nationwide interoperability. HINs must agree on a minimum set of principles that enable trust in order to facilitate interoperability and the exchange of EHI necessary to support the entire care continuum. The TEF Draft 2 establishes a uniform set of principles that all HINs should adhere to allow for the trusted and secure electronic exchange of health information. Adherence to these principles will help improve the flow of EHI, providing patients with secure access to their information when and where they need it most.