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| 1 | +[#vol1_clause_profiles, supplement_sdpi_volume_caption=1] |
| 2 | += Volume 1 -- Profiles |
| 3 | + |
| 4 | +// == Profiles |
| 5 | + |
| 6 | +// TF-1:2 Devices Integration Profiles |
| 7 | + |
| 8 | +[#supplement_vol1_clause_devices_integration_profiles,sdpi_offset=2] |
| 9 | +== Devices Integration Profiles |
| 10 | + |
| 11 | +// 2.2 |
| 12 | +[#suupplement_vol1_clause_ses_considerations_requirements,sdpi_offset=2] |
| 13 | +=== Safety, Effectiveness and Security - Requirements and Considerations |
| 14 | + |
| 15 | +// 2.3 |
| 16 | +[#suupplement_vol1_clause_integration_profiles_overview] |
| 17 | +=== Integration Profiles Overview |
| 18 | + |
| 19 | + |
| 20 | +[#suupplement_vol1_clause_sdpi_integration_profiles_overview] |
| 21 | +==== Service-oriented Device Point-of-care Interoperability (SDPi) |
| 22 | + |
| 23 | + |
| 24 | +[#suupplement_vol1_clause_sdpi_scope] |
| 25 | +===== SDPi Profiles – Scope of Application |
| 26 | + |
| 27 | + |
| 28 | +[#supplement_vol1_clause_sdpi_overview_framework] |
| 29 | +===== SDPi Profiles – Overview & Framework |
| 30 | + |
| 31 | +// Standalone TO DO - Do we have to specialize the "footnote:[...]" as well? |
| 32 | + |
| 33 | +// TF-1:10 SDPi Plug-and-Trust Profile |
| 34 | + |
| 35 | +[#supplement_vol1_clause_sdpi_p_profile,sdpi_offset=10,role=profile,profile-id=sdpi-p,reftext="Plug-and-trust Profile",oid-arcs=.11] |
| 36 | +== Service-oriented Device Point-of-care Interoperability – Plug-and-trust (SDPi-P) Profile |
| 37 | +[#supplement_vol1_clause_sdpi_p_profile_reftext,reftext="SDPi-P Profile"] |
| 38 | + |
| 39 | +The SDPi-Plug-and-trust ([[supplement_acronym_sdpi_p,SDPi-P]] SDPi-P) Profile supports foundational seamless connectivity, information exchange and service invocation as defined in the SDPi architecture detailed in <<supplement_vol1_clause_sdpi_overview_framework>>. |
| 40 | +Whereas the related SDPi Profiles for reporting, alerting and external control are explicitly intended to support medical care capabilities, the SDPi-P Profile focuses on basic healthcare device interoperability. |
| 41 | +All the capabilities defined in SDPi-P are leveraged by and extended in the medically focused profiles. |
| 42 | +This foundational profile not only supports medical device interoperability ("<<supplement_acronym_mdi>>"), providing for “plug-and-play” capabilities, but also with a tightly integrated “trust” framework (see <<supplement_vol1_appendix_a_requirements_management_for_p_n_t_interperability>>). |
| 43 | +The establishment of a trusted ecosystem of medical and non-medical devices and applications footnote:[Note that SDPi-P supports application interoperability including “Software as a Medical Device” (<<acronym_samd>>).] begins at the start of discovery and a secure connection. Therefore, the profile's name: <<supplement_term_plug_and_trust>>. |
| 44 | + |
| 45 | +_This_ is primarily an IHE transport profile footnote:[See the IHE Technical Frameworks General Introduction for a more detailed description of IHE profile types, published at https://profiles.ihe.net/GeneralIntro/[profiles.ihe.net/GeneralIntro/].], although it does define several content modules detailed in IHE Devices TF-3. |
| 46 | +It supports the transactions and information exchanged in accordance to a Service-Oriented Architecture (SOA) specialized for high-acuity points of care (e.g., operating table or ICU bed), defined as a <<supplement_term_service_oriented_medical_device_system>>. |
| 47 | +All the SDPi-P actors are therefore scoped with “<<supplement_acronym_somds>>” to clearly identify their application context and scope. |
| 48 | + |
| 49 | +Although all information exchanged between SDPi-P <<supplement_acronym_somds>> participating systems and applications must conform to the basic <<supplement_acronym_sdc>>/<<supplement_acronym_biceps>> content module requirements footnote:[See <<vol3_clause_sdc_biceps_semantic_content_module>>. ], content modules have been defined for common high-acuity medical devices such as infusion pumps, ventilators and physiologic monitors. |
| 50 | + |
| 51 | +Note that future IHE _workflow profiles_ may be defined that build upon the transport and content module foundation established by the SDPi-P profile. |
| 52 | +For example, Operating Room / Surgery Point-of-Care Integration, ICU Point-of-Care Integration, or more service-focused profiles such as Point-of-Care Identity Management (PCIM) for device-patient association management, or Silent ICU / Quiet Hospital, where the acute point-of-care is integrated with enterprise systems around device alerting and alert distribution to provide an improved environment of care (reduced noise level and improved safety) and clinician interaction. |
| 53 | + |
| 54 | + |
| 55 | + |
| 56 | +// TF-1:11 SDPi - Reporting Profile |
| 57 | + |
| 58 | +[#supplement_vol1_clause_sdpi_r_profile,sdpi_offset=11,role=profile,profile-id=sdpi-r,reftext="Reporting Profile",oid-arcs=.12] |
| 59 | +== Service-oriented Device Point-of-care Interoperability – Reporting (SDPi-R) Profile |
| 60 | + |
| 61 | + |
| 62 | +// TF-1:12 SDPi - Alerting Profile |
| 63 | + |
| 64 | +[#supplement_vol1_clause_sdpi_a_profile,sdpi_offset=12,role=profile,profile-id=sdpi-a,reftext="Alerting Profile",oid-arcs=.13] |
| 65 | +== Service-oriented Device Point-of-care Interoperability – Alerting (SDPi-A) Profile |
| 66 | + |
| 67 | + |
| 68 | +// TF-1:13 SDPi - External Control Profile |
| 69 | + |
| 70 | +[#supplement_vol1_clause_sdpi_xc_profile,sdpi_offset=13,role=profile,profile-id=sdpi-xc,reftext="External Control Profile",oid-arcs=.14] |
| 71 | +== Service-oriented Device Point-of-care Interoperability – external Control (SDPi-xC) Profile |
| 72 | + |
| 73 | +// TF-1:A Appendix A |
| 74 | +[appendix#supplement_vol1_appendix_a_requirements_management_for_p_n_t_interperability,sdpi_offset=A] |
| 75 | +== Requirements Management for Plug-and-Trust Interoperability |
| 76 | + |
| 77 | + |
| 78 | +// TF-1:B Appendix B |
| 79 | +[appendix#supplement_vol1_appendix_b_references,sdpi_offset=B] |
| 80 | +== References |
| 81 | + |
| 82 | + |
| 83 | +// TF-1:C Appendix C |
| 84 | + |
| 85 | +[appendix#supplement_vol1_appendix_c_dpi_use_cases,sdpi_offset=C] |
| 86 | +== Device Point-of-care Interoperability (DPI) Use Cases |
| 87 | + |
| 88 | +:var_use_case_id: 1 |
| 89 | +[#supplement_vol1_clause_appendix_c_use_case_stad,sdpi_offset=2] |
| 90 | +[role=use-case,use-case-id=stad,sdpi_feature="Synchronized Time Across Devices",oid-arcs=".1"] |
| 91 | +=== Use Case Feature {var_use_case_id}: <<supplement_label_use_case_name_stad>> (<<supplement_acronym_stad>>) |
| 92 | + |
| 93 | +:var_use_case_id: 2 |
| 94 | +[#supplement_vol1_clause_appendix_c_use_case_sicdsp,sdpi_offset=3] |
| 95 | +[role=use-case,use-case-id=sicdsp,sdpi_feature="Single Patient Standalone ICU Dashboard",oid-arcs=".2"] |
| 96 | +=== Use Case Feature {var_use_case_id}: <<supplement_label_use_case_name_sicdsp>> (<<supplement_acronym_sicdsp>>) |
| 97 | + |
| 98 | +:var_use_case_id: 3 |
| 99 | +[#vsupplement_ol1_clause_appendix_c_use_case_sicdmp,sdpi_offset=4] |
| 100 | +[role=use-case,use-case-id=sicdmp,sdpi_feature="Multiple Patient Standalone ICU Dashboard",oid-arcs=".3"] |
| 101 | +=== Use Case Feature {var_use_case_id}: <<supplement_label_use_case_name_sicdmp>> (<<supplement_acronym_sicdmp>>) |
| 102 | + |
| 103 | +:var_use_case_id: 4 |
| 104 | +[#supplement_vol1_clause_appendix_c_use_case_ddes,sdpi_offset=5] |
| 105 | +[role=use-case,use-case-id=ddes,sdpi_feature="Device Data to Enterprise Systems",oid-arcs=".4"] |
| 106 | +=== Use Case Feature {var_use_case_id}: <<supplement_label_use_case_name_ddes>> (<<supplement_acronym_ddes>>) |
| 107 | + |
| 108 | +:var_use_case_id: 5 |
| 109 | +[#supplement_vol1_clause_appendix_c_use_case_acns,sdpi_offset=6] |
| 110 | +[role=use-case,use-case-id=acns,sdpi_feature="Alerts to Clinician Notification Systems",oid-arcs=".5"] |
| 111 | +=== Use Case Feature {var_use_case_id}: <<supplement_label_use_case_name_acns>> (<<supplement_acronym_acns>>) |
| 112 | + |
| 113 | +:var_use_case_id: 6 |
| 114 | +[#supplement_vol1_clause_appendix_c_use_case_aars,sdpi_offset=7] |
| 115 | +[role=use-case,use-case-id=aars,sdpi_feature="Alerts to Alert Recording Systems",oid-arcs=".6"] |
| 116 | +=== Use Case Feature {var_use_case_id}: <<supplement_label_use_case_name_aars>> (<<supplement_acronym_aars>>) |
| 117 | + |
| 118 | + |
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