The pe son-r lat ed data car ied b a data card can be cat eg oriz d in thr e bro d ty es: identif ication of the devic it elf an the in ivid al t o w hom the data it car ies r lat es, ad
Patient healthcard data object structure
A collection of fundamental data objects has been developed to enable flexible storage of clinical data, paving the way for future application-specific improvements These tools are intended to support the implementation of common accessory features for stored data, ensuring efficient memory usage, which is crucial for various types of data cards.
The tools consist of a generic data structure based on an object-oriented model represented as an UML class diagram as shown in Figure 1.
Figure 1 — Patient healthcard data — Overall structure
The content of this object-oriented structure is described both below and intrinsically will also require the use of data objects not defined within this document.
Medication data is considered a form of clinical data To facilitate more flexible implementation methods, it is structured as a direct child of the PatientHealthcardData object This approach simplifies the model implementation, making it possible to operate without the need for the complete clinical data set.
NOTE It is possible to take the data objects and recombine them while preserving their context specific tags, and to define new objects, while still preserving interoperability.
This document enables the creation of complex aggregate data objects from simpler components while facilitating associations between specific objects for information sharing This functionality is particularly useful for allowing a collection of accessory attributes to serve multiple stored information objects as services.
Basic data objects for referencing
Overview
A set of useful data type definitions has been established, serving as a foundation for defining other objects in this document These definitions, while lacking intrinsic meaning, facilitate operations with various information objects to enhance usability and fulfill business objectives The formal definitions of these objects are outlined in ISO 21549-2.
Coded data
Coded values are interpreted based on their respective coding systems This document emphasizes that the use of a specific coding system is not obligatory unless explicitly stated.
This document exclusively defines a specific coding scheme, and no alternative schemes are permitted Future modifications to any references to coding schemes not specified here may occur independently of this document.
The data object “CodedData” shall be constructed according to the definition contained in ISO 21549-2.
Device and data security attributes
Data stored in healthcare data cards can be sensitive, prompting the use of security attributes as outlined in ISO 21549-2 This document does not address the actual data content or the mechanisms that utilize these data elements.
It is emphasised that the security attributes cannot satisfy given security requirements without the implementation of the appropriate security functions and mechanisms within the data card.
Access rights to specific data items are assigned to individuals and are shaped by local laws, organizational policies, and legal frameworks These rights are implemented by application developers and can be managed through automated systems, such as health care professional cards Additionally, access rights may vary at the application level, allowing for customization based on specific applications and countries.
The “SecurityServices” data object facilitates the storage of essential data for implementing security functions and mechanisms By allowing data to be “attached” to individual elements, it maintains the original author’s security requirements during data transfers between various forms of data cards This ensures that when data is moved from active to passive media and back, the original security specifications are preserved Additionally, this capability enables precise replication of a data card, such as during regeneration after a failure.
Accessory attributes
The "AccessoryAttributes" data object will include an ordered set of information crucial for documenting the resources accessed and utilized, detailing both the originator of the information and the methods through which it reaches the recipient, as outlined in ISO 21549-2.
6 Functional requirements on card information for prescriptions
Overview of supported uses
Healthcards play a vital role in the medical prescription process by serving two key functions: identifying the patient and the prescribing health professional These essential uses are crucial for the integrity of the prescribing system, although they are not the focus of this document.
This document emphasizes the importance of cards in conveying essential information to healthcare professionals and patients, including non-professional caregivers Additionally, the design of the data sets also takes into account the functionality of transporting new prescriptions from the prescriber to the pharmacy or dispenser.
Carry a prescription from prescriber to the dispenser
General
A healthcard for transmitting prescriptions must include various identifiers for the prescriber, dispensing agent, and subject of care, along with details about the prescribed items The information regarding the subject of care is static and defined by other sections of ISO 21549 Likewise, the identifiers for the prescriber and dispensing agent are also static, with multiple iterations covered by other parts of ISO 21549.
Prescription set
A prescription set consists of multiple medicinal product items prescribed for a single patient by one prescriber during one visit, along with additional relevant information for all items.
Who
This is data relevant for the whole prescription set and has a series of specialisations of healthcare party. Patient
This is the subject of care who is the intended recipient of a prescribed item.
NOTE For healthcards, we are only considering one person, not animals, nor groups of patients.
A healthcare professional, as defined in Clause 3, is specifically responsible for creating prescriptions and granting the authority to dispense medication.
This specialization in healthcare involves one or more insurance companies or entities that play a role in the financial aspects of prescriptions.
NOTE This can include the patient as guarantor.
This is a specialization of a healthcare professional which is a representation of an individual who has a pharmacist status who is filling/dispensing the prescription (see Clause 3).
What
These are the data relevant for a prescription item. a) Name of the medicinal product (see Clause 3):
— identified by brand name, generic name or code values for these (with reference to identification of code set, if used);
Magistral medicinal products, also known as extemporaneous products, are distinct from other medicinal appliances Key factors to consider include strength, drug form, quantity, quantity units, manufacturer, and relevant codes, with the exception of quantity units.
Times
Key time points and intervals for prescription and dispensing include: the authorization date of the prescription, the dispensing date, the validity period defined by medical supply regulations, and the specified interval required between multiple supplies of the same medication.
How
The prescription item includes essential details such as dosage instructions presented in a structured format with coded and numeric elements, along with the prescriber's comments applicable to either a specific item or the entire prescription It also encompasses special prescriptions for narcotics and those requiring a special license Additionally, it outlines substitution rules relevant to the local jurisdiction and specifies the conditions for repeat prescriptions, including the possibility of a time interval Furthermore, the preferred language of the patient and the language of the prescription are both indicated, ensuring clarity and compliance with local regulations.
Card information on dispensed prescriptions
Card information includes data on dispensed items, which can be valuable for health professionals during future dispensing occasions, especially when evaluating new prescriptions It is important to recognize that this information is kept confidential, similar to other clinical data, as patients may not always fulfill their prescriptions.
Medication notes
Healthcards that include prescription information play a crucial role in compiling a comprehensive list of a patient's medications, along with important details regarding the safe use of these medicines, such as allergies and sensitivities This information can be gathered from recorded dispensed prescriptions, but it is also beneficial to document medications that patients purchase or acquire directly.
When designing a system, it is crucial to consider the history of prescriptions in contrast to the current total medication prescribed by one or multiple healthcare providers Additionally, it is important to determine whether to exclude medications that are not currently being taken from the list.
The users of this data are health professionals involved with a patient’s medication management or who have a requirement to understand the medical history of the patient.
Patients and their non-health professional caregivers can access this information, empowering them to make informed decisions.
General
General
MedicationNotes serves as a personal record of pharmaceutical supplies for patients, documenting dispensed medications and self-medications while excluding unused drugs Physicians are required to record medications provided as samples or discharge medications, as well as those used in outpatient or inpatient settings Additionally, it is essential to note patient characteristics that may lead to drug intolerances The MedicationNotes can be integrated with data from specialized information systems in pharmacies, doctor's offices, or hospitals, allowing for automatic evaluation This integration enhances the quality of pharmaceutical care by facilitating the quick identification of multiple prescriptions for similar medications, potential interactions and contraindications, atypical dosages, and the need for guidance when prescribing new medications, such as antibiotics or aerosols, as well as documenting any medication allergies.
The structure of MedicationNotes and associated classes is shown in Figure 3.
MedicationNotes is not intended to provide a comprehensive overview of all medication-related information Instead, it functions as a reference tool and does not relieve physicians or pharmacists of their responsibility to verify warning notices and the underlying data in MedicationNotes.
Individual entities within MedicationNotes are specified in Table 2.
Table 2 — Specification o f individual entities within MedicationNotes
The attribute "medicationHistory" is of the data type MedicationHistory and has a multiplicity of 0 1, indicating that it may or may not be present This attribute captures the medication history of the individual, comprising one or more instances of MedicationReceived, and may also include instances of AccessoryAttributes.
Characteristics 0 1 This attribute holds the medication relevant characteristics record of the recorded person It consists of 1 * instances of PatientCharacteristic and may contain the instance of
Risks 0 1 This attribute holds the known medication risks record of the recorded person It consists of 1 * instances of KnownInteractionOrContraindication and may contain the instance of AccessoryAttributes.
The medication history record tracks all medications supplied or administered to the patient, utilizing a clear drug code linked to a medication database Each new medication entry includes the date and type of dispensation, with repeated dispensations updating the date fields accordingly If a medication is dispensed multiple times, the two most recent dates are recorded, and an iteration flag is activated An archival code is added if it is determined through patient consultation that the medication is no longer in use, but this code is removed if the medication is dispensed again.
The structure of MedicationHistory and associated classes is shown in Figure 4.
Figure 4 — Structure of MedicationHistory Individual entities within MedicationReceived are specified in Table 3.
Table 3 — Specification o f individual entities within MedicationReceived
The article outlines three key attributes related to medication coding The first attribute, genericMedicineCode, is a CodedData type that is optional and can contain the medication code based on international or national classifications, such as ATC or NCDCP, with a free text field available for further refinement The second attribute, proprietaryMedicineCode, also a CodedData type, is optional and includes the code and value from a proprietary nomenclature for the medication received Lastly, the specifiedBrandCode, another CodedData type, is an optional attribute that represents the specific brand of a designated proprietary medicine.
Code for “special” conditions e.g re-imports; used to define the source of the drug The manufacturer may be the same, but source may be different.
The attributes genericMedicineCode, proprietaryMedicineCode, and specifiedBrandCode are conditional, meaning at least one must be present The medicationReceivingDate1 indicates the last date the patient received the medication, while medicationReceivingDate2 reflects the date prior to the last The iterationFlag, when set to TRUE, signifies that the patient has received the medication more than twice Additionally, medicationDeliveryType provides a coded representation of how the medication was received, such as through a prescription or self-administration Lastly, the archivalCode records whether a medication is currently not being taken, using a coded data structure.
The medication characteristics record includes patient details that may indicate contraindications or necessitate careful monitoring when prescribing certain drugs These details can pertain to diagnoses, medical findings, or risk factors, such as allergies, diabetes, pregnancy, or lactation.
The structure of MedicationRelevantCharacteristics and associated classes is shown in Figure 5.
Individual entities within PatientCharacteristic are specified in Table 4.
Table 4 — Specification o f individual entities within PatientCharacteristic
Attribute name Data type Multiplicity Comments characteristicCode CodedData 1 Contains coded data representation of the medication relevant patient characteristic.
If a coding system lacks a necessary patient characteristic, it can be communicated using specific parameters: the coding scheme reference is set to 0, the code data value is marked as “C,” and the characteristic is described in the code data free text along with the entry date Additionally, the recorded by ID identifies the doctor or pharmacist responsible for documenting the characteristic If the archival code is set to TRUE, it signifies that the patient characteristic, such as pregnancy, is no longer applicable.
The medication risks record includes documented interactions between medications and patient characteristics After conducting a risk assessment, the physician has chosen to prescribe the medication A partnership model has been established, consisting of two partners that can be categorized by various fields such as medication, diagnosis, age, and gender, with specified link types including interaction, contraindication, and drug allergy.
The structure of KnownMedicationRisks and associated classes is shown in Figure 6.
Figure 6 — Structure of KnownMedicationRisks Individual entities within KnownInteractionOrContraindication are specified in Table 5.
Table 5 — Specification o f individual entities within KnownInteractionOrContraindication
The article outlines key attributes related to medication risk associated with specified partners The attribute "linkType" is a CodedData type that represents the coded data of the medication risk, which may arise from interactions or contraindications with partners The "firstPartnerType" and "secondPartnerType" attributes, both of CodedData type, provide coded representations of the first and second partner types, respectively, such as drugs Similarly, "firstPartnerCode" and "secondPartnerCode" represent the coded data for the first and second partner values, which can include drugs, allergies, or pregnancy Lastly, the "entryDate" attribute is of Date type and indicates the date of entry for this information.
The MedicationPrescriptions class shall consist of a set of MedicationPrescription, which contains the classes “PrescriptionItem” and may contain the class “AccessoryAttributes” (see Figure 7).
Tables 6 and 7 specify individual entities within MedicationPrescription and PrescriptionItem respectively.
Table 6 — Specification o f individual entities within MedicationPrescription
The attribute "medicationAvailableFrom" is of data type UTCTime and indicates the legal date from which the medication is authorized for dispensing Conversely, the "prescriptionValidUntil" attribute, also of data type UTCTime, signifies the legal date after which the medication should no longer be dispensed.
In certain countries or organizations, the prescription period is defined by legislation, but prescribers can manually set a shorter timeframe Each prescription set is uniquely identified by a string known as the prescriptionSetIdentifier The prescriptionSetIssueDateAndTime indicates when the prescription was issued Additionally, there is an option for a requestedPriorityForDispensing, allowing for expedited handling over routine processes The prescriber, identified as a healthcare professional, is responsible for issuing the prescription, which includes multiple prescription items detailing the prescribed medications.
Table 7 — Specification o f individual entities within PrescriptionItem
The prescription item is uniquely identified by the attribute name "prescriptionItemIdentifier," which is a mandatory string Additionally, the "qualifier" attribute, which is optional, indicates the type of prescribed item, such as acute medication or long-term medication Lastly, the "dosageInstructionsCode" attribute, also optional, provides a coded representation of the instructions for how and when to take the medication.
If a coding system lacks the necessary dosage instruction, it can be conveyed using the following format: codingSchemeRef = 0, codeDataValue = “C”, and codeDataFreeText = text of the instruction The class PrescribedMedicinalProduct 1 contains details about the prescribed manufactured medicinal product, including its specialization.
“PrescribedManufacturedMedicinal Product”, see Table 8) or the information about the prescribed magistral medicinal product (specialization
“PrescribedMagistralMedicinal Product”, see Table 12). patientAdviceCode CodedData 0 1 Contains the coded data representation of additional advice to be given to the recipient of the medication.
If a coding system lacks the necessary patient advice, it can be communicated using the following format: set the codingSchemeRef to 0, codeDataValue to “C,” and include the text of the advice in codeDataFreeText The iterations field, represented as a numeric string (0 1), indicates how many times the prescription may be dispensed, and will only be present if the prescriber intends for the prescription to be filled multiple times Additionally, prescriberEndorsement may include coded data that triggers case-specific events or records specific information, such as the DEA Number Lastly, a comment field may contain any additional information for the dispenser.
MedicationReferences
A "MedicationReferences" data object comprises a collection of "MedicationReference" entries, which serve as the "addresses" for additional resources containing medication data pertinent to the patient.
Individual entities within MedicationReference are specified in Table 27.
Table 27 — Specification o f individual within MedicationRe f erence entities
The article outlines key attributes related to medication prescriptions The "uniqueResourceLocator" is an OCTET STRING that points to the external resource containing the prescribed medication object The "prescriptionSetIdentifier" is a mandatory OCTET STRING that uniquely identifies the prescription set The "prescriptionItemIdentifier" is an optional OCTET STRING that can have multiple entries, representing the unique identification of each prescription item Lastly, the "key" is an optional OCTET STRING that provides a deciphering key for enciphered medication data.
Annex A (normative) ASN.1 data definitions
The following definitions shall be used for all the new implementations of this document.
The following definitions shall be used only for backward compatibility with the first edition of this document These definitions may be obsoleted in future editions.
Annex B (informative) Example of medication notes
Table B.1 illustrates an example of medication notes, highlighting a cardholder with a milk allergy who was administered Nifedipine on September 4, 2003 This individual had a prior history of receiving Nifedipine before June 18, 2003 Additionally, it is important to note the known drug interaction between Nifedipine and Bisoprolol.
Table B.1 — Example of medication notes
Class/Attribute name Data type Example data
- - - - codeDataFreeText String allergic to milk
- - - - codeDataValue String
Class/Attribute name Data type Example data
[1] ISO 7498-2, Information processing systems — Open Systems Interconnection — Basic Reference
[2] ISO 13940, Health informatics — System of concepts to support continuity of care
[3] ISO/IEC 7810, Identification cards — Physical characteristics
[4] ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and times
[5] ISO/IEC 8824 (all parts), Information technology — Abstract Syntax Notation One (ASN.1)
[6] ISO/IEC 8825-1, Information technology — ASN.1 encoding rules: Specification of Basic Encoding
Rules (BER), Canonical Encoding Rules (CER) and Distinguished Encoding Rules (DER)
[7] ISO/IEC 9594-8, Information technology — Open Systems Interconnection — The Directory —
Part 8: Public-key and attribute certificate frameworks
[8] ISO/IEC 9798-1, Information technology — Security techniques — Entity authentication —
[9] ISO/IEC 10181-2, Information technology — Open Systems Interconnection — Security frameworks for open systems: Authentication framework — Part 2
[10] ISO 21089:2004, Health informatics — Trusted end-to-end information flows
[11] ENV 13607, Health informatics — Messages for the Exchange of Information on Medicine