Consent Directive Use Cases

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See also: Glossary of Consent Terms for definition of acronyms and terms.

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Introduction

The following use cases describe requirements for the creation and use of privacy consent directives to express consumer preference in regards personal health record and personally/individually identifiable information. These use cases are based on the recommendation issued by [www.samhsa.gov/ SAMHSA] in May 2008 to the American Health Information Community (AHIC) Consumer Empowerment Workgroup:

Recommendation 1: Personal Health Records should possess the functional and technical capability to enable healthcare consumer control of the collection, access, use, and disclosure of their individually identifiable health information (IIHI) according to the type of information, type of provider, and purposes/circumstance of the collection, access, use, or disclosure. The consumer control capability must remain associated with the IIHI as it travels through the electronic health information exchange such that consumer control is supported when IIHI is further disclosed. Thus, the consumer control of IIHI capability must span Electronic Health Records and Personal Health Recrods. Sarah Wattenberg, May 15th, 2008

Use Cases

Grant Control of Individually Identifiable Health Information(IIHI) to Consumer

This use cases is the basis of the entire Consent Directive specification. If the consumers do not own/control their IIHI, then they cannot specify consent directives.

Basic Scenario

Based on the current regulation, the Jurisdictional Authority assigns the right to control personal health information to the Consumer who is its subject or to their designated Substitute Decision Maker (SDM) that acts on behalf of the Patient.

Post-Condition

The Consumer may consent to assign access to parts of the IIHI to specific providers for treatment or other organization for research, etc.

Actors

See also: Actor definitions

• Jurisdictional Authority
• Patient
• Substitute Decision Maker (SDM)

Consenter Manages Consent Directives

The Consenter, a patient or substitute decision maker uses an eConsent managememnt system (CDMS)via Web portal to manage the eConsent rules that are shared with healthcare providers, payers, and others that may access the consumer's personal health records. The CDMS may embedded in a PHR System or some other publicly accessible healthcare platform.

Pre-condition

• The Consenter will have an access to a set of default enumerated of eConsent options that are appropriate for that jurisdiction.
• An authenticated Consenter and Consumer identity have been established.
• The Consenter may be SDM acting on behalf of a Consumer.
• The consent directive options must be comprehensible by consumers and must allow them to take control of their personal health records

Basic Scenario

• Consenter may add, modify, or revoke consent directive regarding the disclosure of his/her Personal Health Records.
• Verify that added or modified consent directive rules do not conflict with existing federal or local rules.
• The CDMS will include default jurisdictional policy rules that are applicable across all requesting organizations. Other organizational or local jurisdiction policies must be applied by each consent requester. The user must not be able to disable the directives derived from these default jurisdictional policies.
  • For example, universal consent policies are required for Alcohol and Substance Abuse information, as specified by CFR 42, Part 2.

Actors

See also: Actor definitions

• Consenter
• Consent Directives Management Service (CDMS)

Request eConsent for a Consumer

Permission to access, use, update personal health records is determined by both a consumer's eConsent and the policies of the requester's organization and/or governing jurisdiction. The request for a patient's eConsent must discover and reconcile all relevant policies.

Pre-Conditions

• An authenticated Consumer identity has been established.
• The Consenter may be SDM acting on behalf of a Consumer.

Basic Scenario

• The Consent Requester uses the consumer's identity to query the CDMS Registry (if available) and discover location of the specific CDMS that stores the consumer's eConsent.
• Query the CDMS and retrieve the patient's eConsent.
• Reconcile patient's eConsent with requester's organizational and jurisdictional consent rules.
  • If the patient's eConsent contradicts the organizational or jurisdictional policies, then requester must flag conflict and attempt to reconcile the differences.

Alternate Flow

• There are no consent directives for the consumer, or no registered CDMS.
• Apply only the organizational and jurisdictional rules applicable in the requester's jurisdiction.

Post-condition

• The consumer's eConsent is retrieved, if available
• If the consumer's eConsent and the organizational directives cannot be reconciled, the consumer may sign a waiver or refuse medical services.

Actors

See also: Actor definitions

• Consent Requester
• Consent Directives Management Service (CDMS)
• CDMS Registry
• Consumer

Provider Requests Access to Personal Health Records

When a healthcare provider requires access to the patient's medical history, medication list, problems, allergy, etc. stored in the patient's personal health records, the provider must first retrieve any existing eConsent for that patient. Before the personal health records may be viewed, used, and updated by a provider, that patient's eConsent must be retrieved and used to determine the consumer's consents, dissents, or directives regarding their information.

Basic Scenario

• Invoke use case: Request Consent Directives for a Patient.
• Query the repository (or repositories) to retrieve patient's health records including Individually Identifiable Health Information (IIHI)
• Invoke use case: Consent Directives Filter Health Record Information
  • Use the consent directive rules to filter the patient healht records allowing only content appropriate for the various type of professionals involved in direct care (e.g. nurses, physicians), supporting care (e.g medical technicians, dietitians, etc), administration, and payment.

Post-condition

• The Provider's EHRS stores a copy of the patient's health record that was created in by that provider. This information must be retained for legal reasons.
• The Provider's EHRS must update the patient's health record in the appropriate repository with the new data that was created by the provider. The Provider must flag the perosonla health records created during the visit and the Individually Identifiable Health Information (IIHI) contained in it according to the patient's eConsent.

Actors

See also: Actor definitions

• Provider's EHR System (EHRS)
• PHR Repository

Filter Health Record Information based on Consumer Preferences

Filtering mechanisms and algorithms are required that apply eConsent rules describing the consumer's preferences to that individual's personal health records. Consent directives may include restricted access filters that are applied to a category of health information (e.g., all HIV related information). A consent directive may also require that personally identified health information is "masked" to protect the patient's sensitive information.

Pre-conditions

• Instead of having generic functional role, provider's role is based on their relationship to the patient. For example, a member of the immediate care team (e.g. attending physician, nurses providing direct care, etc.) may be allowed to see and update the personal health records while other clinicians (e.g. laboratory medical technicians, consulting physicians, etc.) will be allowed access only to the information intended for their use (e.g. laboratory order or consult request).
• A provider requests a patient's health record in order to provide care to the patient. The information is provided in the form of structured or unstructured clinical documents.

Basic Scenario

Depending on whether the information is structured or unstructured, filtering may be applied at the record or document level, or on subsections. Structured information, which is encoded data, can be filtered at the data element level. Unstructured information, which is unencoded data that may be transmitted, e.g., as an image or bit map, can only be filtered at the document or document section level.

Actors

See also: Actor definitions

• Consent Directives Management Service (CDMS)
• Consent Requester

Flag Filtered Health Record Information

If Consenter decides to restrict certain information, he may have the option of deciding whether to permit IIHI Repository to send a flag to an authorized party alerting the Consent Requester that restricted information is available upon Consenter's approval or by "breaking the glass" in an emergency. "Breaking the glass" occurs when a provider who is authorized by organizational policy or jurisdictional law overrides a consent directive.

Basic Scenario

Authorize a specified type of provider to access all restricted health information, and to receive a flag that restricted information may be accessed, following Consenter's approval. A provider's use of restricted information is limited to read-only for a specified time period, after which the consent approval will expire.

Actors

See also: Actor definitions

• Consenter
• Consent Requester
• Consent Directives Management Service (CDMS)
• IIHI Repository

Provider Maintains PHR based on Consumer's Consents and Directives

If the consumer requested it, the provider will update the IIHI stored at a location specified by the patient at the end of a visit, encounter, procedure, etc.

Pre-condition

The provider is given access to the IIHI and the consent directive,

Post-condition

• The provider produce additional information as a result treating the patient.
• The consumer's PHR is updated in the IIHI Repository.
• It must be possible to interpret the information added to the IIHI such as a system can correctly differentiate information that my be sensitive under jurisdictional, organizational, or consent directive.

Actors

See also: Actor definitions

• Consenter
• Provider
• PHR Producer