Skip to content
搜索以了解InterSystems产品和解决方案,职业机会等。

Advisory: Advance Directive Status Value Derived from CDA and C-CDA May Be Misleading

This problem affects the following products:

  • HealthShare Unified Care Record, all versions
  • HealthShare Clinical Viewer, all versions
  • HealthShare Health Connect, all versions
  • InterSystems IRIS for Health, all versions

The Advance Directive streamlet in the SDA data model contains a Status property which is populated by CDA and C-CDA transformations. The Status is derived as “Active” or “Inactive” depending upon data in the CDA or C-CDA document.

In a C-CDA 1.1 or C-CDA 2.1 document:

  • if the Advance Directive observation entry has an effectiveTime set in the past or the entry's effectiveTime/high is null or absent, the SDA Advance Directive Status property will be set to “I” for “Inactive”.
  • If the entry's effectiveTime is in the future, the SDA  Status property will be set to “A” for “Active”.

Unless updated data is later received, this value will not be updated when the effectiveTime has passed.

For example, in the following Advance Directive entry in a C-CDA 1.1 or C-CDA 2.1 document, the value for effectiveTime/high is in the future. This will be derived as an SDA Status equal to “A”. When the effectiveTime/high date passes, the SDA Status value will not be updated unless updated data is received by the system.

<entry>
<observation classCode="OBS" moodCode="EVN">
<templateId root="2.16.840.1.113883.10.20.22.4.48"/>
<!-- ** Advance Directive Observation ** -->
<id root="9b54c3c9-1673-49c7-aef9-b037ed72ed27"/>
<code code="304251008" codeSystem="2.16.840.1.113883.6.96" displayName="Resuscitation"/>
<statusCode code="completed" />
<effectiveTime>
<low value="20210101"/>
<high value="20230101"/>
</effectiveTime>
...
</entry>

NOTE: the C-CDA 1.1 and 2.2 specifications require that statusCode is always equal to “completed”. Therefore, it is not meaningful to determine whether the Advance Directive is active or not.

Within the out-of-the-box Clinical Viewer, Advance Directives are displayed as part of the Alert profile page and include the data items Alert Category, Alert, Message, External ID, Entered On and Create User Role. Prior to Clinical Viewer version 2022.1, Status and End Date were not available in the Alert profile page.

This may pose a clinical safety risk as the Advance Directive is inappropriately represented as active when it has expired or is inappropriately represented as inactive when it is in effect. In either situation, the Advance Directive may be improperly applied, resulting in potential harm to the patient. Within the Clinical Viewer, users may not be aware that the information being displayed has expired.

The following mitigating factors have been identified:

  • The “Active” Status value is accurate at the time the data is ingested.
  • If the document is reprocessed, the Status value will be updated using the current date.
  • If an updated document is received, the Status value will be updated using the current date.
  • The effectiveTime values are retained. They are stored in the SDA AdvanceDirective streamlet ToTime and FromTime properties. 
  • This issue does not affect data from CDA C32 documents. See the Additional Information section of this advisory for more information.
  • The out-of-the-box Clinical Viewer 2022.1 displays both the Status (Status) and End Date (ToTime) data items. Users may reference both values to better assess the status of the information. 

Who is Affected by This Issue

  • HealthShare customers are affected by this issue if they ingest C-CCDA 1.1 or C-CDA 2.1 documents containing Advance Directive data.
  • Health Connect and IRIS for Health customers are affected by this issue if they ingest C-CCDA 1.1 or C-CDA 2.1 documents containing Advance Directive data and they store that data in SDA.
  • Within Clinical Viewer, HealthShare customers are affected by this issue if the standard display for alerts within the Clinical Viewer is used.

A fix is not yet available for the core issue affecting the validity over time of Status values within HealthShare. A fix is available for Clinical Viewer to display the Status and End Date data items in the Alert display. The Clinical Viewer fix is included in the 2022.1 release and can be requested as an ad hoc patch in HSCV-10983.

InterSystems recommends that customers apply the Clinical Viewer fix and notify their users and recipients of outbound data that Advance Directive Status information should not be relied upon for clinical decision making.

Additional Information

InterSystem's CDA C32 document transformation is not affected by this issue. It derives the SDA Status value differently than the C-CDA 1.1 and 2.1 transformations. The CDA C32 specification permits the usage of an Advance Directive Status Observation which has a required ValueSet 2.16.840.1.113883.1.11.20.1 AdvanceDirectiveStatusCode. This ValueSet is detailed in the table below. Note that the displayName values for these codes have evolved over time, the table below shows the displayName values as they are documented in the CDA C32 specification.

AdvanceDirectiveStatusCode:

code
displayName
codeSystem
Code System Name
425392003
Current and Verified
2.16.840.1.113883.6.96
SNOMED CT
425394002
Supported By Healthcare Will
2.16.840.1.113883.6.96
SNOMED CT
425393008
Supported By Durable Power of Attorney for Healthcare
2.16.840.1.113883.6.96
SNOMED CT
425396000
Verified With Family Only
2.16.840.1.113883.6.96
SNOMED CT
310305009
Verified By Medical Record Only
2.16.840.1.113883.6.96
SNOMED CT

The InterSystems CDA C32 data transformation will derive a value of “A” for “Active” if the Advance Directive Status Observation has a value matching one of the codes above or the additional SNOMED codes 425397009 (Active advance directive with verification by healthcare professional (finding)) and 425395001 (Active living will). All other values, or null values, will be derived as “I” for “Inactive”.

Reference Information

The core data issue is identified as HSIEC-4365.

The Clinical Viewer fix is identified as HSCV-10983. HSCV-10983 is included in the Clinical Viewer 2022.1 release and can be requested as an ad hoc patch from the Worldwide Response Center (WRC).

If you have any questions regarding this alert, please contact the WRC.

最新警报和通知

Jun 11, 2025
Advisory ID Product & Versions Affected Risk Category & Score Explicit Requirements DP-439649 Products:
May 02, 2025
InterSystems 已经解决了影响在 InterSystems IRIS、InterSystems IRIS for Health、HealthShare、HealthShare HealthConnect、TrakCare、Caché 和 Ensemble 上使用 OAuth2 Client 配置的应用程序的安全漏洞。 补救步骤和其他指导文档可从 InterSystems 全球响应中心 (WRC) 获取。
Apr 08, 2025
受影响的产品和版本 明确要求 DP-439207 InterSystems IRIS® data platform 2024.3 (AIX) 在AIX(操作系统)安装过程中使用JSON处理以及支持Unicode非拉丁语系-1字符集 DP-439280 InterSystems IRIS 2024.3(使用 IntegratedML 的容器) 使用 TensorFlow 的 IntegratedML 容器
Feb 22, 2025
InterSystems 已纠正了两个可能导致少数 SQL 查询返回不正确结果的问题。 此外,InterSystems 还纠正了日期/时间数据类型处理中的不一致性,对于依赖于先前不一致性行为的现有应用程序来说,这种不一致性可能会导致不同的、意想不到的但正确的结果。
Feb 19, 2025
InterSystems 已修复一个缺陷,该缺陷导致在使用特定 $LIST 语法时引入无效的数据库和日志记录。 遇到这种缺陷的可能性很低,但对运营的影响可能很大。
Oct 09, 2024
InterSystems 已经解决了影响 InterSystems IRIS、InterSystems IRIS for Health、HealthShare、HealthShare HealthConnect、TrakCare、Caché 和 Ensemble 的 Web 网关和 CSP 网关的安全漏洞。可从 InterSystems 全球响应中心 (WRC) 获取补救步骤和其他指导文件。在讨论本通知时,请参考 "SVR2024A"。 如需修复帮助,请联系您的应用程序提供商或 InterSystems 全球响应中心。
Aug 21, 2024
InterSystems 已修复了一个缺陷,在极少数情况下,该缺陷可能导致多卷数据库出现数据库损坏或 错误。只有被截断的数据库才存在风险。
Jun 03, 2024
从发布InterSystems IRIS®数据平台2022.3开始,InterSystems修改了许可证强制执行机制,以包括REST和SOAP请求。由于这种变化,在升级后,使用REST或SOAP的非处理器核数的许可证环境下,用户可能会遇到更高的许可证消耗。要确定此警报是否适用于您的InterSystems许可证,请按照下面链接的FAQ中的说明进行操作。
May 01, 2024
InterSystems has corrected an issue that can cause a small number of SQL queries to return incorrect results. See below for the specifics on impacted queries.
Nov 14, 2023
There are 10 alerts in the HealthShare HS2023-02 Alert communication. An alert summary for each issue is shown is in the table below. Details for each alert are contained in the attached document: HS2023-02-Communication.