A patient's standing restriction on the collection, use or disclosure of their own personal
health information -- the instruction PHIPA calls a lockbox.
Elements / Details
Every element this profile touches, with its full definition. Element names in the tables link here.
A patient's standing restriction on their own record (lockbox)
Definition
Records an instruction from the patient, or from a person authorized to instruct on their behalf,
restricting what may be done with their personal health information.
One directive per instruction, superseded rather than edited. Unlike item consent, which keeps
one resource per item and updates it in place, a directive is a statement made at a moment. When
the patient changes their instruction, the prior directive moves to inactive and a NEW directive
records the new instruction. The reason is evidentiary: a directive is the thing an auditor holds
up to justify or condemn a disclosure decision, and "what did this say on the day we released the
record" must be answerable without reconstructing it from version history.
Absence of a directive is not permission. It means no restriction has been recorded. Whether
a disclosure is lawful without one is a question for the applicable policy and the purpose of the
disclosure, not a question this resource answers. A consumer MUST NOT treat "no directive found"
as an authorization; it is the absence of one input to a decision that has other inputs.
Finding a patient's directives. Select the family, then filter on status:
GET Consent?patient={id}&category=../CodeSystem/nexus-consent-family|privacy-directive&status=active
Omitting the category returns app consents and item consents alongside directives, and all three
carry scope = patient-privacy, so scope will not separate them.
Comments
Broadly, there are 3 key areas of consent for patients: Consent around sharing information (aka Privacy Consent Directive - Authorization to Collect, Use, or Disclose information), consent for specific treatment, or kinds of treatment, and general advance care directives.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
The version specific identifier, as it appears in the version portion of the URL. This value changes when the resource is created, updated, or deleted.
Comments
The server assigns this value, and ignores what the client specifies, except in the case that the server is imposing version integrity on updates/deletes.
When the resource last changed - e.g. when the version changed.
Comments
This value is always populated except when the resource is first being created. The server / resource manager sets this value; what a client provides is irrelevant. This is equivalent to the HTTP Last-Modified and SHOULD have the same value on a read interaction.
Identifies EMR instance & pipeline version the resource came from
Definition
A URI that identifies the EMR pipeline and version from which this resource originated. This tells you which EMR instance (recommend using the instance identifier), and the version of the pipeline code/transformations.
Comments
In the provenance resource, this corresponds to Provenance.entity.what[x]. The exact use of the source (and the implied Provenance.entity.role) is left to implementer discretion. Only one nominated source is allowed; for additional provenance details, a full Provenance resource should be used.
This element can be used to indicate where the current master source of a resource that has a canonical URL if the resource is no longer hosted at the canonical URL.
It is up to the server and/or other infrastructure of policy to determine whether/how these claims are verified and/or updated over time. The list of profile URLs is a set.
Security labels applied to this resource. These tags connect specific resources to the overall security policy and infrastructure.
Comments
The security labels can be updated without changing the stated version of the resource. The list of security labels is a set. Uniqueness is based the system/code, and version and display are ignored.
Tags applied to this resource. Tags are intended to be used to identify and relate resources to process and workflow, and applications are not required to consider the tags when interpreting the meaning of a resource.
Comments
The tags can be updated without changing the stated version of the resource. The list of tags is a set. Uniqueness is based the system/code, and version and display are ignored.
A set of rules under which this content was created
Definition
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Comments
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.
Cardinality
0..1
Type
uri
Modifier
yes — This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation
The base language in which the resource is written.
Comments
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
Definition
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Comments
Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.
Comments
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels.
May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Cardinality
0..*
Type
Extension
Modifier
yes — Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Stable identifier for the instruction, carried so that a directive can be correlated with the
paper or portal request that created it, with a superseding directive, and with an audit entry
that names the directive a decision relied on.
Deliberately NOT a deterministic key derived from patient and type. Item consent uses such a key
because exactly one resource exists per pair and a writer needs to create-or-update in one call.
A directive is the opposite case: several may be active for one patient at once, and a
conditional update keyed on the patient would overwrite an unrelated restriction.
Comments
This identifier identifies this copy of the consent. Where this identifier is also used elsewhere as the identifier for a consent record (e.g. a CDA consent document) then the consent details are expected to be the same.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
Requirements
Allows users to make use of identifiers when the identifier system is not known.
Comments
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Establishes the namespace for the value - that is, a URL that describes a set values that are unique.
Requirements
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
Comments
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the Rendered Value extension. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
active (in force) | inactive (superseded or withdrawn) | entered-in-error
Definition
Whether this directive is currently operative. It is not the decision. The decision -- what is
restricted, from whom -- is in the provision tree.
- active — in force. The restriction stated in the provisions applies now, subject to
provision.period where one is given.
- inactive — no longer operative. R4 defines this as terminated or replaced, which is
exactly right here: the patient withdrew the restriction, or a superseding directive replaced
it. Both are recoverable from identifier and version history.
- entered-in-error — recorded wrongly. Ignore it; it was never an instruction.
draft and proposed are legal against the required base binding and carry no meaning in this
profile. rejected is legal too and MUST NOT be written here: on the item-consent profile it
means the patient declined, and a reader who has seen that family will carry the wrong reading
across.
Why inactive here and rejected there. The two profiles take opposite readings of the same
vocabulary, deliberately. Item consent keeps one resource per item and updates it in place, so it
needs one current-state code meaning "not permitted" whether the patient declined or withdrew;
rejected carries that. A directive is superseded rather than updated, so a withdrawn restriction
is a terminated one, which is what inactive means. Neither profile is reading the vocabulary
loosely; they are modelling different lifecycles and the codes follow.
Requirements
The Consent Directive that is pointed to might be in various lifecycle states, e.g., a revoked Consent Directive.
Comments
This element is labeled as a modifier because the status contains the codes rejected and entered-in-error that mark the Consent as not currently valid.
Cardinality
1..1
Type
code
Must Support
yes
Modifier
yes — This element is labelled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Fixed to patient-privacy. Required by R4 and correct here, but it is NOT a discriminator: app
consent and item consent fix the same value, so a consumer separating families on scope will
separate nothing. Use the category family slice.
Cardinality
1..1
Type
CodeableConcept
Must Support
yes
Modifier
yes — Allows changes to codes based on scope selection
MUST carry the privacy-directive family code; this is how a reader knows what status means
Definition
Required. Carries the family code that tells a consumer which interpretation contract applies
before it reads any other element.
Slicing is open, so a deployment may carry additional classifications alongside — a jurisdictional
code, a workflow bin — but only the family slice identifies the family, and a consumer MUST NOT
infer the family from any other category, from scope, or from the shape of the provision tree.
Comments
The family coding sits outside HL7's consent-category value set on purpose, for the same reason
the item-consent catalogue does: that value set classifies consent DOCUMENTS (advance directive,
notice of privacy practices, research information access) and holds no concept for "which
interpretation contract governs this resource", which is what this element answers.
Terminology-aware validators may note that the base extensible binding is unmet. That note is
expected.
Required. Carries the family code that tells a consumer which interpretation contract applies
before it reads any other element.
Slicing is open, so a deployment may carry additional classifications alongside — a jurisdictional
code, a workflow bin — but only the family slice identifies the family, and a consumer MUST NOT
infer the family from any other category, from scope, or from the shape of the provision tree.
Comments
The family coding sits outside HL7's consent-category value set on purpose, for the same reason
the item-consent catalogue does: that value set classifies consent DOCUMENTS (advance directive,
notice of privacy practices, research information access) and holds no concept for "which
interpretation contract governs this resource", which is what this element answers.
Terminology-aware validators may note that the base extensible binding is unmet. That note is
expected.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
A reference to a code defined by a terminology system.
Requirements
Allows for alternative encodings within a code system, and translations to other code systems.
Comments
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
The identification of the code system that defines the meaning of the symbol in the code.
Requirements
Need to be unambiguous about the source of the definition of the symbol.
Comments
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously.
The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Comments
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Requirements
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
Comments
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Requirements
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
Comments
Very often the text is the same as a displayName of one of the codings.
The patient/healthcare consumer to whom this consent applies.
Comments
Required by this profile rather than inherited. R4's ppc-2 invariant is meant to require a
patient whenever scope is privacy, but its published expression tests system='something' and
therefore never fires. Do not rely on it.
When the patient gave this instruction — not when the resource was stored, and not when the
restriction takes effect. Effect is provision.period.start, which may be later.
Three different times matter to an auditor reconstructing a decision and they must not be
conflated: when the patient said it (here), when it started applying (provision.period.start),
and when the server learned about it (meta.lastUpdated). A directive given on Monday, effective
Wednesday, entered Friday is an ordinary and lawful record.
Comments
This is not the time of the original consent, but the time that this statement was made or derived.
Who gave the instruction -- the patient, or a substitute decision-maker
Definition
Who made this decision. The patient, or the RelatedPerson authorized to decide on their behalf.
A substitute decision-maker is a RelatedPerson, never the Patient. The tender requires access
and correction rights to be exercisable by an individual "and their Substitute Decision Makers",
and recording an SDM's instruction as though the patient gave it destroys the fact that authority
was delegated — which is the fact a privacy office checks when the instruction is challenged.
Practitioner and PractitionerRole are permitted for the staff member who RECORDED the instruction.
Both may appear together, and where they do the reading is that the patient decided and the staff
member wrote it down.
A resource naming ONLY staff is not malformed. A restriction is applied by an administrator acting on
what the patient asked for, and a deployment that captures the administrator without separately
identifying the patient as decision-maker is recording what it actually knows. What it costs is the
ability to show, later, that the instruction came from the individual rather than from the clinic --
which is worth capturing where the workflow can.
Comments
Commonly, the patient the consent pertains to is the consentor, but particularly for young and old people, it may be some other person - e.g. a legal guardian.
The custodian whose records this directive restricts
Definition
The health information custodian this instruction is addressed to.
Load-bearing where it is present, because a restriction on one custodian's records says nothing
about another's. A patient who locks their record at this clinic has not thereby locked the
provincial EHR, and a patient who restricts the provincial EHR has not restricted this clinic. A
directive that names no organization is scoped by the deployment's own policy, which must state
what that scope is rather than leaving a reader to assume it means "everywhere".
The source on which this consent statement is based. The source might be a scanned original paper form, or a reference to a consent that links back to such a source, a reference to a document repository (e.g. XDS) that stores the original consent document.
Comments
The source can be contained inline (Attachment), referenced directly (Consent), referenced in a consent repository (DocumentReference), or simply by an identifier (Identifier), e.g. a CDA document id.
The document the patient signed, or the portal submission that recorded the instruction.
Routed through DocumentReference rather than carried inline so that DocumentReference read
permission gates the document itself: a reader entitled to know THAT a restriction exists is not
automatically entitled to read the patient's written explanation of why.
Comments
The source can be contained inline (Attachment), referenced directly (Consent), referenced in a consent repository (DocumentReference), or simply by an identifier (Identifier), e.g. a CDA document id.
The policy or statutory provision this directive is made under
Definition
A URI identifying the policy under which this instruction is given and must be honoured — a
PHIPA provision, an Ontario Health EHR policy, or the custodian's own published privacy policy.
Required here, and it is what satisfies R4's ppc-1 invariant ("Either a Policy or PolicyRule").
policyRule is deliberately NOT used on this profile. Its binding is to
consentpolicycodes, a code system that contains no Canadian policy concept at all — its 27
codes are US federal and state instruments plus Netherlands, Austria and Switzerland. There is no
code in it that means "a restriction under PHIPA", and the nearest-looking one, cric, is
45 CFR 46: the US Common Rule for human-subjects research. A privacy directive is not research
consent, and a policy element that pointed at one would be a false statement about the legal basis
of the restriction, made in the resource an auditor reads to check exactly that.
Carrying the actual policy URI says the true thing and stays machine-readable. Where a Canadian
policy code system emerges, policyRule becomes available without this element changing.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Extensions that cannot be ignored even if unrecognized
Definition
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Cardinality
0..*
Type
Extension
Modifier
yes — Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The references to the policies that are included in this consent scope. Policies may be organizational, but are often defined jurisdictionally, or in law.
Comments
This element is for discoverability / documentation and does not modify or qualify the policy rules.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Extensions that cannot be ignored even if unrecognized
Definition
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Cardinality
0..*
Type
Extension
Modifier
yes — Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The restriction: type states the decision, and nested provisions carve out exceptions
Definition
The base rule. type = deny for a lockbox: the patient is restricting something.
Exceptions are NESTED provisions with type = permit, describing what the restriction does not
reach -- a care team that may still see the record, or a standing break-glass carve-out.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Extensions that cannot be ignored even if unrecognized
Definition
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Cardinality
0..*
Type
Extension
Modifier
yes — Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The decision this directive states. deny restricts; permit grants.
Required on the root, which diverges from R4's element text. R4 says type is "Not permitted in
root rule, required in all nested rules". IHE PCF and Ontario's PCOI both require it on the root
anyway, and this guide follows them: a directive whose base rule states no decision states none
where a reader looks first, and every reader of this family will be looking there.
A consumer reading a directive that carries no root type MUST NOT infer permit. Treat it as
malformed and fail closed.
When the restriction is effective, if it is time-bounded
Definition
The window in which this restriction applies. An absent period means the restriction applies for
as long as the directive is active, with no end.
An absent period.end means the same thing and must be read that way. A consumer that treats a
missing end as "expired" or as "unknown, therefore ignore" will release restricted information.
Whom the restriction is against, where it names anyone
Definition
The recipient, agent or class of agents the restriction applies to.
actor.reference names an individual practitioner, an organization, or a Group standing for a
class of recipients. actor.role says how they are involved. The tender requires restrictions
naming "specific HIC's, agents, classes of HICs or agents, or individual providers", and a class
is expressed as a Group rather than as a bare code, because a consumer has to be able to test
membership at decision time rather than interpret a label.
An absent actor restricts EVERYONE, on the same fail-closed reasoning as action.
A first-pass limit, stated because the tender asks for the case this does not yet cover. The
requirement names restrictions against "classes of HICs or agents", and a class is properly a Group
whose membership a consumer can test at decision time. Reference(Group) is permitted here, but
this guide does not profile Group and publishes no example of one, so a deployment naming a class
today is pointing at a resource with no agreed shape. Naming an Organization instead works and is
coarser: it covers everyone at that custodian rather than a named subset. What would settle it is a
Group profile and a decision about who maintains membership.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Extensions that cannot be ignored even if unrecognized
Definition
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Cardinality
0..*
Type
Extension
Modifier
yes — Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The resource that identifies the actor. To identify actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers').
Which acts are restricted: collect | access | use | disclose
Definition
The acts this directive restricts, matching PHIPA's collection / use / disclosure triad plus
access for retrieval that permits none of them.
A deliberate divergence from IHE PCF, which prohibits this element entirely (0..0 in all
three of its tiers). PCF targets document-sharing environments, where disclosure is effectively the
only act in play, so the axis buys nothing there. A primary-care EMR is the case it does not cover:
a restriction on internal USE of a record by staff who already hold it is a different instruction
from a restriction on DISCLOSING it outward, and Ontario requires both to be expressible. A
directive exported toward a PCF-conformant system loses this element, and what it meant has to be
carried some other way or declared unsupported at the boundary.
An absent action restricts EVERY action. This is stated rather than left to inference because
the opposite reading — an unnamed action is unrestricted — fails open, and a privacy control that
fails open is not a control. A writer who means to restrict only disclosure must say disclose.
Comments
Note that this is the direct action (not the grounds for the action covered in the purpose element). At present, the only action in the understood and tested scope of this resource is 'read'.
Restrict by sensitivity class -- read the high-water-mark warning first
Definition
Restricts records carrying a given security label rather than records named individually.
R4 matching here is not equality, and the difference is dangerous. The specification states:
"If the consent specifies a security label of 'R' then it applies to all resources that are
labeled 'R' or lower. E.g. for Confidentiality, it's a high water mark." So a directive written
to restrict only restricted material also restricts everything normal, moderate, low and
unrestricted — which, in a chart where most resources carry no elevated label at all, is very
close to restricting the entire record.
A writer meaning "restrict the sensitive material" and reaching for R will get a far broader
restriction than intended. Because that error over-restricts rather than over-discloses it will
not cause a privacy breach, but it will cause a clinician to be denied information they are
entitled to, at a moment when they may need it.
Prefer explicit provision.data selectors for a first implementation. Use this element only where
the deployment has tested subsumption behaviour against both a higher and a lower classification
than the one it names.
Comments
If the consent specifies a security label of "R" then it applies to all resources that are labeled "R" or lower. E.g. for Confidentiality, it's a high water mark. For other kinds of security labels, subsumption logic applies. When the purpose of use tag is on the data, access request purpose of use shall not conflict.
The class of information covered by this rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to.
Comments
Multiple types are or'ed together. The intention of the contentType element is that the codes refer to profiles or document types defined in a standard or an implementation guide somewhere.
Clinical or Operational Relevant period of time that bounds the data controlled by this rule.
Comments
This has a different sense to the Consent.period - that is when the consent agreement holds. This is the time period of the data that is controlled by the agreement.
Which records are restricted, where the directive names records
Definition
The specific records this restriction covers. Absent means the restriction covers the patient's
whole record, which is the ordinary lockbox case.
data.meaning is required by R4 and decides how far the reference reaches: instance is that
resource alone, related includes what it points at, dependents includes what points at it,
authoredby covers everything authored by the referenced actor. Choosing instance where the
patient meant "this visit and everything from it" under-restricts, and it under-restricts
silently.
A first-pass limit worth knowing before designing against it. These selectors enumerate
records that exist NOW. A directive meant to cover future information — "nothing from this clinic,
ever" — cannot be expressed as a list, and this release does not define a criteria-based selector.
Express a whole-record restriction by naming no data at all; that reading does extend to future
records. A directive naming a data list does NOT.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Extensions that cannot be ignored even if unrecognized
Definition
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Cardinality
0..*
Type
Extension
Modifier
yes — Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
Carve-outs from the base rule, each with an explicit type (R4 requires one here and so does this
profile). On a deny directive these are the permissions that survive the restriction.
This is where break-glass lives. A standing exception naming the users who may reach the record
in an emergency is a nested permit whose purpose is BTG and whose actor names the privileged
group:
That shape is IHE PCF's, adopted rather than reinvented. It says who MAY break the glass. It never
says that anybody did -- the record of an actual override, by whom, when, on what lawful ground
and reaching what, is an AuditEvent following IHE BALP's authorization pattern. A deployment that
recorded override events by editing this resource would rewrite the patient's instruction every time
a clinician acted on it, and would make "what did the patient actually ask for" unanswerable.
Nested exceptions do not nest further. R4 permits deeper trees and PCF forbids them; this profile
follows PCF, because a rule whose meaning depends on three levels of precedence is one nobody
implements the same way twice.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Extensions that cannot be ignored even if unrecognized
Definition
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Cardinality
0..*
Type
Extension
Modifier
yes — Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Extensions that cannot be ignored even if unrecognized
Definition
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Cardinality
0..*
Type
Extension
Modifier
yes — Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
The resource that identifies the actor. To identify actors by type, use group to identify a set of actors by some property they share (e.g. 'admitting officers').
Note that this is the direct action (not the grounds for the action covered in the purpose element). At present, the only action in the understood and tested scope of this resource is 'read'.
A security label, comprised of 0..* security label fields (Privacy tags), which define which resources are controlled by this exception.
Comments
If the consent specifies a security label of "R" then it applies to all resources that are labeled "R" or lower. E.g. for Confidentiality, it's a high water mark. For other kinds of security labels, subsumption logic applies. When the purpose of use tag is on the data, access request purpose of use shall not conflict.
The class of information covered by this rule. The type can be a FHIR resource type, a profile on a type, or a CDA document, or some other type that indicates what sort of information the consent relates to.
Comments
Multiple types are or'ed together. The intention of the contentType element is that the codes refer to profiles or document types defined in a standard or an implementation guide somewhere.
Clinical or Operational Relevant period of time that bounds the data controlled by this rule.
Comments
This has a different sense to the Consent.period - that is when the consent agreement holds. This is the time period of the data that is controlled by the agreement.
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Extensions that cannot be ignored even if unrecognized
Definition
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Requirements
Modifier extensions allow for extensions that cannot be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the definition of modifier extensions.
Comments
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Cardinality
0..*
Type
Extension
Modifier
yes — Modifier extensions are expected to modify the meaning or interpretation of the element that contains them