Draft Detailed Use Case

Transcription

1 U.S. Department f Health and Human Services Office f the Natinal Crdinatr fr Health Infrmatin Technlgy Remte Mnitring

2 Remte Mnitring Table f Cntents 1.0 Preface Intrductin and Scpe Use Case Stakehlders Issues and Obstacles Use Case Perspectives Use Case Scenaris Remte Mnitring Infrmatin Exchange Remte Mnitring Dataset Cnsideratins...29 Appendix A: Glssary...32 Office f the Natinal Crdinatr fr Health Infrmatin Technlgy ii

3 Remte Mnitring List f Figures Figure 3-1. Remte Mnitring Use Case Stakehlders Table...5 Figure 7-1. Remte Mnitring...16 Figure 7-2. Remte Mnitring Scenari Flws...17 Figure 7-3. Remte Mnitring, Clinician Perspective...18 Figure 7-4. Remte Mnitring, Care Crdinatr Perspective...21 Figure 7-5. Remte Mnitring, Patient Perspective...23 Figure 8-1. Remte Mnitring Infrmatin Exchange Capabilities...27 Office f the Natinal Crdinatr fr Health Infrmatin Technlgy iii

4 Remte Mnitring 1.0 Preface Use cases develped fr the American Health Infrmatin Cmmunity (AHIC) are based n the pririties expressed by the AHIC, which include needs expressed by the AHIC Wrkgrups. These high-level use cases fcus n the needs f many individuals, rganizatins, and systems rather than the develpment f a specific sftware system. The use cases describe invlved stakehlders, infrmatin flws, issues, and system needs that apply t the multiple participants in these arenas. The use cases strive t prvide enugh detail and cntext fr standards harmnizatin, certificatin cnsideratins, architecture specificatins and detailed plicy discussins t advance the natinal health infrmatin technlgy (HIT) agenda. These high-level use cases fcus, t a significant degree, n the exchange f infrmatin between rganizatins and systems rather than the internal activities f a particular rganizatin r system. During the January 2007 AHIC meeting, nine pririty areas (representing ver 200 identified AHIC and AHIC wrkgrup detailed issues and needs) were discussed and cnsidered. Three f these areas (Cnsumer Access t Clinical Infrmatin, Medicatin Management, and Quality) were selected fr use case develpment and the final 2007 Detailed Use Cases were published in June, The remaining six pririty areas frm the January 2007 AHIC meeting (Remte Mnitring, Patient-Prvider Secure Messaging, Persnalized Healthcare, Cnsultatins & Transfers f Care, Public Health Case Reprting, and Immunizatins & Respnse Management) are nw being develped int the 2008 Use Cases which will be prcessed in the natinal HIT agenda activities in The 2008 Use Cases are being develped by the Office f the Natinal Crdinatr fr Health Infrmatin Technlgy (ONC) with pprtunities fr review and feedback by interested stakehlders within bth the private and public sectrs. T facilitate this prcess, the use cases are being develped in tw stages: The Prttype Use Cases describe the candidate wrkflws fr the use case at a high level, and facilitate initial discussin with stakehlders; and The Detailed Use Cases dcument all f the events and actins within the use case at a detailed level. This dcument is the. Feedback received n the Prttype Use Case has been cnsidered and incrprated where applicable int this dcument. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 1

5 Remte Mnitring This is divided int the fllwing sectins: Sectin 2.0, Intrductin and Scpe, describes the pririty needs identified by ne r mre AHIC wrkgrups and includes draft decisins made regarding the scpe f the use case. Sectin 3.0, Use Case Stakehlders, describes individuals and rganizatins that participate in activities related t the use case and its cmpnents. Sectin 4.0, Issues and Obstacles, describes issues r bstacles which may need t be reslved in rder t achieve the capabilities described in the use case. Sectin 5.0, Use Case Perspectives, describes hw the use case cmbines similar rles (r actrs) t describe their cmmn needs and activities. The rles are intended t describe functinal rles rather than rganizatins r physical entities. Sectin 6.0, Use Case Scenaris, describes hw varius perspectives interact and exchange infrmatin within the cntext f a wrkflw. Use case scenaris prvide a cntext fr understanding infrmatin needs and are nt meant t be prescriptive. Sectin 7.0 prvides a greater level f detail fr each scenari and includes infrmatin flws. Specific events and actins fr each perspective and scenari are presented and discussed. These are als nt intended t be prescriptive. Sectin 8.0, Infrmatin Exchange, describes the rle f infrmatin exchange in the use case at a high level. Sectin 9.0, Dataset Cnsideratins, identifies specific infrmatin pprtunities relevant t this use case that may supprt future standardizatin and harmnizatin activities. Appendix A, the Glssary, prvides draft descriptins f key cncepts and terms cntained in the draft detailed use case. Fllwing receipt f feedback frm interested stakehlders, ONC will develp a final detailed use case. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 2

6 Remte Mnitring 2.0 Intrductin and Scpe In January 2007, the AHIC apprved a recmmendatin t develp a use case addressing remte mnitring. The ability fr a clinician t mnitr patient infrmatin captured remtely, such as physilgical, diagnstic, medicatin tracking, and activities f daily living (ADL) measurements, may be a key enabler fr the management f chrnic health prblems and initial management f new cnditins. Remte mnitring may als be a cmpnent f maintaining wellness fr the aging ppulatin. Measurement devices designed fr use by the patient r a patient caregiver can cmmunicate measurements t a clinician s electrnic health recrd (EHR) and/r the patient s persnal health recrd (PHR). The Remte Mnitring Detailed Use Case will fcus n the cmmunicatin f interperable remte mnitring infrmatin frm applicatins r devices t the EHR and the PHR. In specific terms: Patients and clinicians may benefit frm the ability fr the patient t gather and cmmunicate remte mnitring infrmatin electrnically frm measurement devices in a hme r ther nn-clinical setting t a clinician s EHR system and/r t the patient s PHR. Remte mnitring culd include, but is nt limited t, cmmunicatin f: physilgic measurements (e.g., weight, bld pressure, heart rate and rhythm, pulse ximetry, glucse, etc.), diagnstic measurements (e.g., transthracic impedance, etc.) medicatin tracking device infrmatin (e.g., medicatin pumps, infusin devices, electrnic pillbxes, etc.), and activities f daily living measurements (e.g., ADL bisensrs, pedmeters, sleep actigraphy, etc.). Interperable, user-friendly technlgies are needed t enable the flw f infrmatin t EHRs and PHRs utilized by clinicians, care crdinatrs, patients, and family caregivers respnsible fr their care. One f the gals f the AHIC is establishing a pathway, based n cmmn data standards, t facilitate the incrpratin f interperable, clinically useful remte mnitring infrmatin int EHRs and PHRs t supprt clinical decisin-making and management f patients with chrnic cnditins. This use case addresses areas fr many stakehlders wh are active in the develpment and implementatin f EHRs, PHRs, and ther remte mnitring tls including thse engaged in activities related t standards, interperability, harmnizatin, architecture, plicy develpment, and certificatin. There are a variety f mechanisms by which the remte mnitring infrmatin can be cmmunicated t the EHR r PHR. The mst cmmn mechanism is via an infrmatin exchange capability prvided by a device data intermediary. The device data intermediary serves as the direct interface t extract and stre remte mnitring infrmatin frm the device. The infrmatin exchange may prvide a mechanism fr clinicians and care crdinatrs (such as case managers, physician ffice supprt persnnel, clinical call Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 3

7 Remte Mnitring centers, etc.) t access and review remte mnitring infrmatin and determine the infrmatin t be cmmunicated t the clinician s EHR, r just a mechanism t access data frm many individual devices, and transmit them t different EHRs and PHRs. Remte mnitring infrmatin may als be cmmunicated t an EHR r PHR via ther health infrmatin exchange capabilities r health data banks. Lastly, a remte mnitring device may cnnect directly t an EHR r PHR via a direct device interface, althugh this methd is less prevalent in the market tday. The Remte Mnitring Detailed Use Case will fcus n the infrmatin needs t cmmunicate infrmatin t the EHR r PHR specifically, nt the cmmunicatin frm the device itself t an infrmatin intermediary. The demands fr remte mnitring infrmatin at times supprt needs fr care crdinatrs r ther clinical supprt persnnel wh can mnitr trends in data. Care crdinatin can include a variety f tasks; sme may be mre clinical in nature and supprt the clinician, while thers may be mre patient-riented, and prvided by caregivers, call centers, and health plan case managers. Care crdinatrs that serve in this rle and are likely t need access t detailed measurements, while clinicians preferences may range frm access t cmprehensive raw data t a summarized dataset, which may include cmments and interpretatins prvided by the care crdinatr. Clinicians may als serve as the care crdinatr and perfrm the functins described in this use case in bth the clinician and care crdinatr rles. Decisin supprt capabilities may exist within the device itself, infrmatin intermediary r exchange, EHR, r PHR. Decisin supprt may be as simple as threshld testing that accesses remte mnitring data and generates alert infrmatin. The design f decisin supprt rules that may utilize remte mnitring infrmatin are nt within the scpe f this use case. Hwever, rules may be set and alert infrmatin may be cmmunicated as part f the cmmunicatin f infrmatin t the EHR r PHR. This use case assumes the develping presence f electrnic systems such as EHRs, PHRs, infrmatin intermediaries, and ther lcal r Web-based slutins supprting patients and clinicians, while recgnizing the issues and bstacles assciated with these assumptins. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 4

8 Remte Mnitring 3.0 Use Case Stakehlders Figure 3 1. Remte Mnitring Use Case Stakehlders Table Stakehlder Care Crdinatrs Cntextual Descriptin Individuals wh supprt clinicians in the management f health and disease cnditins. These can include case managers and thers. Clinical Supprt Staff Individuals wh supprt the wrkflw f clinicians. Healthcare prviders with patient care respnsibilities, including physicians, Clinicians advanced practice nurses, physician assistants, nurses, and ther credentialed persnnel invlved in treating patients. Members f the public that include patients as well as caregivers, patient Cnsumers advcates, surrgates, family members, and ther parties wh may be acting fr, r in supprt f, a patient receiving r ptentially receiving healthcare services. Organizatins that prvide tls t aid in the understanding and treatment f Decisin Supprt Tl Prviders health and disease cnditins. These tls encmpass a wide range f capabilities that may be useful and available t patients, cnsumers, clinicians, and ther health prfessinals. Device Data Intermediary Prviders Organizatins that prvide a direct device interface t btain, stre, and/r view measurement data frm remte devices. Organizatins which assist in prviding EHR capabilities t cnsumers. These Electrnic Health Recrd Service Prviders capabilities may include prviding services using infrmatin which is gathered/stred frm a separate rganizatin. Organizatins that prvide these capabilities may include: vendrs, healthcare prviders, health data banks, healthcare payrs, etc. A multi-stakehlder entity, which may be a free-standing rganizatin (i.e., Gegraphic Health Infrmatin Exchange/Reginal Health Infrmatin Organizatins hspital, healthcare system, partnership rganizatin, etc.) that supprts health infrmatin exchange and enables the mvement f health-related data within state, lcal, territrial, r jurisdictinal participant grups. Activities supprting health infrmatin exchanges may als be prvided by entities that are separate frm gegraphic health infrmatin exchanges/reginal Health Infrmatin Organizatins including integrated delivery netwrks, health recrd banks, and thers. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 5

9 Remte Mnitring Stakehlder Cntextual Descriptin Entities/mechanisms fr hlding an individual s lifetime health recrds. This Health Recrd Banks infrmatin may be persnally cntrlled and may reside in varius settings such as hspitals, dctr s ffices, clinics, etc. Health Researchers Organizatins r individuals wh use health infrmatin t cnduct research. Organizatins that are engaged in r supprt the delivery f healthcare. These rganizatins culd include hspitals, ambulatry clinics, lng-term care facilities, Healthcare Entities cmmunity-based healthcare rganizatins, emplyers/ccupatinal health prgrams, schl health prgrams, dental clinics, psychlgy clinics, care delivery rganizatins, pharmacies, and ther healthcare facilities. Insurers, including health plans, self-insured emplyer plans, and third party administratrs, prviding healthcare benefits t enrlled members and Healthcare Payrs reimbursing prvider rganizatins. As part f this rle, they prvide infrmatin n eligibility and cverage fr individual cnsumers, as well as claims-based infrmatin n cnsumer medicatin histry. Case management r disease management may als be supprted. Medical Device Manufacturers/Suppliers Organizatins that design, build, sell, r supprt the use f medical devices by cnsumers t supprt their health needs with crdinated assistance frm clinical and ther health supprt persnnel. Members f the public wh receive healthcare services. Fr hspice prviders, the Patient patient and family are cnsidered a single unit f care. Synnyms used by varius health care fields include client, resident, custmer, patient and family unit, cnsumer and health care cnsumer. Organizatins which assist in prviding PHR capabilities t cnsumers. Persnal Health Recrd Service Prviders Organizatins that prvide these capabilities may include: vendrs, healthcare prviders, health data banks, healthcare payrs, referral management prviders, etc. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 6

10 Remte Mnitring 4.0 Issues and Obstacles Realizing the full benefits f HIT is dependent n vercming a number f issues and bstacles in tday s envirnment. Inherent is the premise that sme f these issues and bstacles will be crss-cutting and therefre shwn in all use cases, while thers are unique t this specific use case. Issues and Obstacles which are applicable acrss use cases appear belw in prblem and cnsequence frm: Cnfidentiality, privacy, and security: Cnsumers may require privacy cntrls fr persnal health infrmatin that gvern hw patient data is accessed, viewed, and cmmunicated. Privacy cntrls and the means f restricting data access, which are available fr paper-based recrds, are nt currently available fr electrnic recrds. Withut permissins and cntrls, cnsumer participatin in the act f electrnic health infrmatin exchange may be limited. There are regulatins cncerning the strage, transmissin, r destructin f electrnic health infrmatin. These regulatins are incnsistent acrss federal, state, and lcal jurisdictins. Withut cnsistent standards, the viewing, accessing, r transmitting f electrnic health infrmatin may be inhibited. Infrmatin integrity, interperability, and exchange: Incmplete, inaccurate, r prprietarily-frmatted infrmatin prevents efficient exchange r utilizatin f electrnic health infrmatin. Withut data standards that prmte cmpatibility and interperability, lngitudinal patient medical recrds may be incmplete r f questinable integrity. EHR and HIT adptin: The prcesses identified in the use cases rely upn successful integratin f EHRs int clinical activities. Because this integratin may nt align with current wrkflw and may require additinal upfrnt csts, it may nt be widely pursued r implemented. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 7

11 Remte Mnitring Lw adptin f HIT, particularly within rural areas and lng-term care settings, may create disparate service levels and may adversely affect healthcare fr these ppulatins. Lack f business mdel and infrastructure: Financial incentives are nt currently sufficient t prmte the business practices necessary fr sustainable HIT. If sufficient reimbursement plicies and ther financial incentives are nt established, HIT adptin may be difficult r unsustainable. Activities invlving health infrmatin exchange will require additinal technical infrastructure, functinality, and rbustness, beynd what is currently available. Unless the requisite infrastructure fr health infrmatin exchange capabilities is established, imprved upn, and sustained, these capabilities may have limited success and prvide few benefits. Clinical Decisin Supprt: The capabilities, requirements, and standards needed fr cnsistent develpment and implementatin f Clinical Decisin Supprt have nt been identified. The utility and benefits f Clinical Decisin Supprt cannt be fully realized withut the develpment f wrkflws and standards demnstrating benefits fr cnsumers, patients, and prviders. In additin t the crss-cutting issues and bstacles described abve, several ther issues r bstacles exist that are specific t this use case. Cnfidentiality, privacy, and security: Alng with allwing cnsumers t cntrl wh can access their persnally cntrlled health infrmatin, the cnsumer needs t be able t cntrl the specific infrmatin that can be accessed. This cntrl is nt widely implemented tday. Patients may be reluctant t make remte mnitring infrmatin accessible t clinicians and care crdinatrs unless they have adequate assurance that their cncerns abut cnfidentiality, privacy and security have been addressed. Patients will want cnfidentiality, Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 8

12 Remte Mnitring access cntrl and infrmatin describing wh has had access t their infrmatin. Remte mnitring infrmatin culd be utilized by EHRs and ther applicatins fr secndary uses such as research and device safety and recall needs. The use f infrmatin fr secndary use must be adequately cntrlled and managed. Standards fr these secndary uses d nt exist. Withut cnsistent standards, secndary uses f remte mnitring infrmatin may be limited and patient privacy culd be cmprmised. Lack f business mdel and infrastructure: The develpment f a clear business case fr cst-savings r quality imprvement has nt been established, as a number f pilt tests are currently being cnducted in the market t evaluate the impact f remte mnitring n imprved health utcmes and csts. If a business case r quality imprvement impacts are nt established, remte mnitring adptin may be difficult r unsustainable. All payr prgrams d nt currently reimburse fr the purchase, peratin, and maintenance f remte mnitring devices fr clinician-rdered remte mnitring. Sme payrs have setup payr-based disease management prgrams that prvide remte mnitring devices and care managers. Health care clinicians may nt be reimbursed fr time spent with (and expertise prvided t) patients t supprt the remte mnitring f their cnditins utside f the ffice setting. If reimbursement plicies and ther financial incentives are nt established, remte mnitring adptin may be difficult r unsustainable. Data validatin, verificatin, and reliability As remte mnitring takes place withut direct supervisin, there is a greater ptential risk fr self-diagnsis r imprper respnse t mnitring data. Infrmatin types generated by remte mnitring devices must be adequately understd by all parties invlved in their use including patients, patient surrgates, clinicians, and care crdinatrs. Mechanisms d nt currently exist t ensure that the infrmatin transmitted is reliable, accurate, and representative f the apprpriate patient. Prviding Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 9

13 Remte Mnitring adequate safeguards t prtect the data during infrmatin exchange activities is anther dimensin f this need. Clinicians may be reluctant t access remte mnitring infrmatin unless they have adequate assurance that the data is valid, accurate, and reliable. There shuld be mechanisms fr a clinician and/r care crdinatr t determine the surce f the data (e.g. device-generated vs. patient-entered data). Clinicians may have preferences regarding acceptance r review f device-generated infrmatin due t ptential reliability issues assciated with patient-entered data. Clinicians will want remte mnitring infrmatin t be fr the right patient, right device, right date/time, and the right/accurate measurement. The device, patient, and prvider s identity shuld be registered and verified befre remte mnitring infrmatin is acted upn. Withut mechanisms t ensure that remte mnitring infrmatin is accurate and cntains minimal device, calibratin, and transmissin errrs, market adptin f remte mnitring by clinicians may be limited. Remte mnitring data standardizatin Currently, a standardized nmenclature fr describing devices and data has nt been established. Data utputs frm devices must als be standardized s widespread use f devices and their data streams is pssible with minimal custmizatin f supprting systems. Standards develpment effrts are needed t develp unifrm mechanisms t cmmunicate remte mnitring infrmatin. Remte mnitring infrmatin frm varius manufacturers and exchanges need t utilize interperable data, including the same units f measure t prevent inaccurate r cnflicting clinical results. Withut standardizatin f remte mnitring infrmatin such as units f measure, adptin f remte mnitring may be segmented amng technlgy prviders (brands) and thus verall adptin may be limited. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 10

14 Remte Mnitring Remte mnitring infrmatin may need t adhere t medical device reprting requirements requiring the ability f the device and infrmatin intermediaries t cmmunicate device identificatin infrmatin t the prvider/caregiver fr cmplete disclsure. Withut standardizatin f device identificatin, the ability t adhere t medical device reprting requirements may be limited. Althugh EHRs and PHRs may be available, a standardized interface fr remte mnitring technlgy is nt. A standardized remte mnitring interface with determinatins regarding the detail, structure, and quantity f patient infrmatin t be stred may nt exist with EHRs and PHRs, limiting widespread adptin. Patient/Cnsumer Educatin and Supprt Patients and family caregivers may require assistance and educatin in learning hw t utilize and calibrate the device t btain accurate measurements. Assistance r supprt may als be required subsequent t initial setup at ther times during the remte mnitring. Withut adequate educatin and supprt, remte mnitring infrmatin received by clinicians and care crdinatrs may nt be accurate and quality f care may be impacted. Patients, family caregivers, and patient surrgates may require assistance in the registratin and setup prcess t determine the apprpriate authenticatin and authrizatin cntrls, identify the authrized recipients f mnitring data, and cnfiguring device cnnectivity. Inadequate training r assistance may prevent the transmissin f remte mnitring infrmatin t EHRs and PHRs and limit widespread use and adptin. Medical practice and state laws Wide-spread remte mnitring may require analysis and change t existing laws and regulatins related t treating/mnitring patients and use f remte assessment infrmatin despite the clinician s physical lcatin and scpe f practice. Medical practice may be inhibited by additinal administrative burden and legal cncerns regarding clinician respnsibility fr remte Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 11

15 Remte Mnitring mnitring infrmatin that may be cntained within an EHR and use f cnsumer vs. regulated medical devices. Legal medical recrd Regulatry and prcess cnsideratins regarding whether remte mnitring infrmatin shuld be included as part f the legal medical recrd need t be cnsidered. Withut clarity abut the scpe f the legal medial recrd, particularly as it relates t remte mnitring data, clinical interpretatin, r summary analysis, adptin f remte mnitring by clinicians may be limited. Infrmatin included in a medical recrd culd include a vetting r attestatin step, where a medical prfessinal reviews and accepts the data as part f the recrd. Clinicians may want t receive ntificatin and chse whether t accept remte mnitring infrmatin, especially when it may nt be rdered by the clinician (e.g. initiated by the patient, initiated by payr disease management prgrams, etc.). Withut the ability fr clinicians t specify the desired scpe f remte mnitring infrmatin, clinicians may be verwhelmed by the amunt f nn-pertinent infrmatin received, r questin the reliability f limited infrmatin. Unless clinicians have the ability t designate the amunt f remte mnitring infrmatin that can be accepted int an EHR, such as the ability accept all remte mnitring infrmatin r nly summary infrmatin that has been reviewed r analyzed by a care crdinatr, adptin may be limited. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 12

16 Remte Mnitring 5.0 Use Case Perspectives The Remte Mnitring fcuses n the exchange f physilgical and ther test measurements between patient s mnitring devices and their clinicians (and the clinicians supprting systems). The use case will describe remte mnitring frm three perspectives. The perspectives are representative f rles and functins, rather than rganizatins r physical lcatins. Each perspective is described belw: Clinician The clinician perspective includes physicians, nurses, nurse practitiners, physician assistants, and ther clinical persnnel wh clinically evaluate the remte measurements in the EHR and determine apprpriate clinical interventins if needed t manage patient care. Clinicians may als serve as the care crdinatr and perfrm the rles and functins described in this use case in bth the clinician and care crdinatr perspectives. Care Crdinatr The care crdinatr perspective includes clinically-trained individuals wh mnitr the infrmatin received frm the patient s device(s). Care crdinatrs assist the patient and/r clinician in managing remte mnitring infrmatin and culd include clinicians, nurses, caregivers, case managers, hme health resurces, and payr case managers. The care crdinatr may help patients understand their cnditins, assist with device training, remind patients t take their measurements, and assist patients in fllwing their care plans and treatment regimens. A care crdinatr may intervene if measurements indicate that there has been a change in the patient s health status, r if the measurements fall utside f a predetermined range. The care crdinatr may als infrm the patient s clinician if measurements indicate a ptential health issue. Finally, the care crdinatr may help determine the need fr an immediate face-t-face visit r urgent/emergency care. The care crdinatr may determine the relevant infrmatin that needs t be cmmunicated t the clinician t determine apprpriate clinical interventins. The care crdinatr may be the same individual as the clinician respnsible fr care and management f the patient and culd perfrm the rles and functins described in bth the clinician and care crdinatr perspectives. Patient The patient perspective is cmprised f the patient, family caregivers, patient surrgates, advcates, and ther parties wh may be acting fr, r in supprt f, a patient, wh culd use a remte mnitring device t gather measurements. These measurements are then cmmunicated t the apprpriate clinician s EHR via an infrmatin intermediary which culd be prvided by a device manufacturer r ther Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 13

17 Remte Mnitring entity based upn authrizatin f the patient. The patient measurements may be taken in varius nn-clinical settings such as at hme, at wrk, at schl, while traveling, r assisted living facilities. These perspectives are the fcus f the events detailed in the scenaris described in Sectin 6.0. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 14

18 Remte Mnitring 6.0 Use Case Scenaris The Remte Mnitring fcuses upn the exchange f remte mnitring devices used t gather and cmmunicate measurements frm the patient s lcatin t the apprpriate care crdinatrs and/r clinicians. Remte Mnitring The patient r caregiver prepares the device fr use and cmmunicatin. This may invlve registering the device with the manufacturer and/r setting up the cmmunicatins capabilities f the device. The patient r caregiver uses the remte mnitring device t gather patient measurements. Measurements culd be cmmunicated each time the device gathers the data r the accumulated measurements culd be cmmunicated peridically (e.g., daily). Measurements culd be cmmunicated t an infrmatin exchange, such as a device intermediary, t the patient s PHR, r t an EHR directly. The mechanisms t btain device cnnectivity and cmmunicate data frm the device itself can vary greatly based upn clinical gals and bjectives, device types, cmmunicatin prtcls, and manufacturer design. Therefre, direct device cnnectivity between the infrmatin intermediary and the device is nt a fcus f this use case. With apprpriate safeguards fr patient privacy and security, a care crdinatr may review the measurement infrmatin received via a prtal prvided by an infrmatin intermediary, such as a device data intermediary prvided by the device manufacturer r a third party, r within the EHR. Care crdinatrs may interact directly with the patient r caregivers t verify the infrmatin received and gather additinal infrmatin abut the patient s situatin. If a clinician review, analysis, r interventin is needed, remte mnitring infrmatin and any additinal infrmatin abut the patient s situatin is cmmunicated t the clinician s EHR. The clinician reviews the remte mnitring infrmatin received and determines if a patient evaluatin r change in treatment plan is necessary. Upn cmpletin f the patient evaluatin and mdified treatment plan, the apprpriate infrmatin may be cmmunicated t the care crdinatr and the patient s PHR. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 15

19 Remte Mnitring 7.0 Remte Mnitring Figure 7 1. Remte Mnitring Perspectives/Rles Infrmatin Surces & Recipients Sectin 7.1 Clinician Sectin 7.2 Care Crdinatr Sectin 8.0 Infrmatin Intermediary Sectin 7.3 Patient Primary Care/ Other Prviders Evaluate patient & determine need fr remte mnitring Initiate remte mnitring & crdinate with patient Device Intermediary OR Obtain & set up device fr remte mnitring PHRs Order remte mnitring Receive remte mnitring summary Access r receive mnitring data Determine if clinician interventin is needed Health Infrmatin Exchange 8.1 Register device, patient and data recipient 8.2 Data retrieval Utilize device t btain measurements Transmit mnitring data frm device Health Recrd Banks Evaluate/ manage patient Determine if patient cmmunicatin is needed Data delivery Patient mdifies meds dsage, activities, diet, etc Mdify treatment plan & cmmunicate with patient Cmmunicate mnitring infrmatin Subject-data matching Patient discusses treatment plan with clinician Patient implements mdified treatment plan Legend Fcus Cntextual Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 16

20 Remte Mnitring Figure 7 2. Remte Mnitring Scenari Flws Patient and device registratin infrmatin. Remte mnitring data riginating frm device t device manufacturer interface. Remte mnitring data is cmmunicated t electrnic patient recrds. Mnitring summary infrmatin is cmmunicated t the clinician. Clinician mdificatins in treatment plan is cmmunicated t the patient and ther recipients. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 17

21 Remte Mnitring Cde Descriptin Cmments Figure 7 3. Remte Mnitring, Clinician Perspective Event: Evaluate patient and determine need fr remte mnitring Actin: Evaluate patient and rder tests as apprpriate. The patient is seen by the clinician fr a wellness visit, new prblem, r fllw-up visit fr existing cnditin(s). The clinician may rder tests and enact a care plan as apprpriate. The care plan may include the prescribing f medicatins and prviding recmmendatins t the patient fr managing their disease r wellness plan (e.g., diet, activity, etc) Actin: Evaluate patient and recmmend remte mnitring. The clinician recmmends remte mnitring and discusses the prcess with the patient r family caregiver a Alternative Actin: Receive ntice f patient enrllment in remte mnitring r disease management prgram. Remte mnitring may be initiated by disease management prgrams. The disease management prgram ntifies the clinician that the patient has been enrlled in a disease/remte mnitring prgram b Alternative Actin: Receive ntice f patient selfinitiated remte mnitring. The patient may acquire a remte mnitring device with the ability t send the data t a health recrd bank, device data intermediary, r ther methds f infrmatin exchange. This may prvide a mechanism t send remte mnitring data t clinician EHRs Event: Order remte mnitring Actin: Clinician rders remte mnitring. The clinician rders remte mnitring fr the patient. This may invlve ntificatin t a care crdinatr within the clinician s ffice r anther care crdinatr t initiate the remte mnitring prcess with the patient r patient s caregiver a Alternative Actin: Clinician receives ntificatin f a patient request t send remte mnitring infrmatin t the clinician s EHR. The clinician may chse t accept r deny receipt f patient-initiated remte mnitring data depending upn whether the clinician r clinician ffice may be respnsible fr reviewing and mnitring the infrmatin. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 18

22 Remte Mnitring Cde Descriptin Cmments Actin: Clinician perfrms setup required t accept patient remte mnitring infrmatin within the clinician s EHR. The clinician r supprt staff establishes required authenticatin and authrizatin t receive patient mnitring infrmatin within the clinician s EHR. This prcess may als be accmplished by the care crdinatr n the clinician s behalf Event: Receive remte mnitring summary Actin: Remte mnitring infrmatin is cmmunicated t the clinician s EHR. Remte mnitring infrmatin is received in the clinician s EHR. The clinician may be ntified f receipt f remte mnitring infrmatin based upn the design r cnfiguratin f the clinician s EHR. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 19

23 Remte Mnitring Cde Descriptin Cmments Actin: Clinician reviews remte mnitring infrmatin within the EHR. The remte mnitring infrmatin may be frmatted and displayed in the clinician s EHR t facilitate review and interpretatin. The infrmatin cmmunicated t the clinician s EHR may include all measurements cmmunicated by the patient s device r it may be an excerpted set f measurements identified fr clinician review by a care crdinatr. If the remte mnitring infrmatin was reviewed by a care crdinatr, the infrmatin received in the EHR may cntain assessment infrmatin such as a summary f the care crdinatr s findings/recmmendatins, summary f interactin with patient, r specific items fr the clinician t cnsider, etc. The remte mnitring infrmatin cmmunicated t the EHR includes data that may r may nt be utilized by the decisin supprt t alert the clinician. Alert infrmatin may be generated by the device, data intermediary r infrmatin exchange and may be cmmunicated t the clinician s EHR. The clinician is able t determine the surce f the measurement data (e.g. direct device generated r patient entered), the date/time f the measurement, any patient-entered supprting data. Clinicians can benefit in receiving remte mnitring infrmatin frm a disparate set f surces and device manufacturers t facilitate review f remte device measurements within an EHR Event: Evaluate/manage patient Actin: The clinician may recmmend patient fllw-up based upn remte infrmatin received. The clinician may recmmend that the patient schedule a fllw-up ffice visit, seek urgent/emergency care, r have a discussin regarding the patient s adherence t the recmmended care plan (e.g. medicatins, diet, activity, etc.) Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 20

24 Remte Mnitring Cde Descriptin Cmments Actin: The clinician evaluates the patient. The clinician evaluates the patient and may rder tests, etc. if apprpriate Event: Mdify treatment plan and cmmunicate with patient Actin: The clinician mdifies the patient s treatment plan if required. The clinician may need t mdify the patient s care plan based upn remte mnitring infrmatin received and evaluatin f the patient Actin: The clinician cmmunicates a change in care plan t the patient and ther infrmatin recipients. The clinician may update the patient s care plan including mdificatin f medicatins, etc. The mdified care plan and recmmendatins may be electrnically accessed by the patient as described in Cnsumer Empwerment: Cnsumer Access t Clinical Infrmatin Use Case. Cde Descriptin Cmments The mdified care plan infrmatin may als need t be cmmunicated t ther prviders r care crdinatrs that are managing the patient. Figure 7 4. Remte Mnitring, Care Crdinatr Perspective Event: Initiate remte mnitring and crdinate with patient Actin: Initiate remte mnitring fr the patient. The care crdinatr may be a clinician supprt staff member, patient caregiver, r care manager as part f a payr r disease management prgram. The care crdinatr may receive a ntificatin frm the patient s clinician t initiate remte mnitring r may initiate remte mnitring as part f a disease management prgram Actin: Crdinate with patient t setup remte mnitring. The care crdinatr may cntact the patient t crdinate acquisitin, setup, and any necessary training fr the remte mnitring device. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 21

25 Remte Mnitring Cde Descriptin Cmments Actin: Setup remte mnitring infrmatin recipients. The care crdinatr may crdinate with the patient t register the device t cmmunicate measurements t a device data intermediary r infrmatin exchange and als set up authrized recipients f remte mnitring infrmatin. In sme instances, the device may be able t cmmunicate measurements t the clinician s EHR directly. Device registratin may still need t ccur t setup the recipients f the mnitring infrmatin Event: Access r receive mnitring infrmatin Actin: The care crdinatr reviews a patient s remte mnitring infrmatin via infrmatin intermediary. A care crdinatr may access data via a data intermediary r infrmatin exchange t review patient remte mnitring infrmatin. The data intermediary may be a device manufacturer prtal, ther 3rd party applicatin, r health infrmatin exchange prvided fr review f remte mnitring infrmatin. The care crdinatr must pssess the necessary user privileges and authrizatins t access patient data. The access and view f remte mnitring data cntained within the infrmatin intermediary is nt a fcus f this use case a Alternative Actin: The care crdinatr will receive remte mnitring infrmatin within an EHR. A care crdinatr will review remte mnitring infrmatin within the EHR Event: Determine if clinician interventin is needed Actin: The care crdinatr may cntact a clinician if needed. A care crdinatr may discuss patient care details with the clinician r determine that the patient shuld seek urgent r emergency care. The care crdinatr may have access t decisin supprt alerts that were generated by the device, infrmatin intermediary, r EHR based upn the patient measurement data Event: Determine if patient cmmunicatin is needed Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 22

26 Remte Mnitring Cde Descriptin Cmments Actin: The care crdinatr may cmmunicate with the patient t verify remte mnitring infrmatin received r discuss care management details. A care crdinatr may cntact the patient t validate the measurement data reviewed prir t acting upn any measurements that are a cause fr cncern. The care crdinatr may als cntact the patient t determine whether the patient is fllwing the recmmended care plan and prvide supplemental assistance. The care crdinatr may remind the patient t take their measurements, determine additinal remte mnitring training needs, validate/manage medicatin cmpliance, and fllw-up n general chrnic care management r wellness items Event: Cmmunicate mnitring infrmatin Actin: Care crdinatr dcuments summary f clinician and/r patient interactin. The care crdinatr may dcument a summary f clinician and patient interactins in the EHR r within the infrmatin intermediary (e.g., device data intermediary prtal, etc.) Actin: Care crdinatr cmmunicates remte mnitring infrmatin and assessment infrmatin t the clinician. The care crdinatr may direct the cmmunicatin f remte mnitring infrmatin t the clinician r this may be an autmated functin. The care crdinatr may send all available measurement data, r select a subset t be cmmunicated t the clinician s EHR. Included with the measurement data cmmunicated t the clinician s EHR may be assessment infrmatin r recmmendatins the care crdinatr prvides the clinician a Alternative Actin: Care crdinatr reviews remte mnitring infrmatin within the EHR and ntifies the clinician. If the care crdinatr has already received the remte mnitring infrmatin within the EHR, the care crdinatr may need t ntify the clinician that fllw-up is needed. This may be perfrmed within the EHR r accmplished via ther mechanisms such as secure messaging r a phne call. Figure 7 5. Remte Mnitring, Patient Perspective Cde Descriptin Cmments Event: Obtain and set up device fr remte mnitring Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 23

27 Remte Mnitring Cde Descriptin Cmments Actin: Patient btains remte mnitring device. A patient may be instructed t begin remte mnitring by a clinician, thrugh a disease management prgram, r thrugh a self-initiated chrnic care r wellness management prgram. The device may be prvided t the patient, r the patient may need t btain their device n their wn Actin: Patient cmpletes educatin n device use. The patient may cmplete self-directed training via instructins r nline educatin, r the patient may receive training frm a care crdinatr r training prgram n device use and calibratin Actin: Patient sets up the device t cmmunicate measurement infrmatin t clinicians and/r care crdinatrs. The patient registers the device with an infrmatin intermediary t cmmunicate measurement data t the apprpriate recipients such as clinicians and care crdinatrs. The patient may need t establish an identificatin cde, passwrd, and ther security measures t enable cmmunicatin f measurement data. The patient may prvide authrizatin t clinicians and care crdinatrs t access and/r receive measurement data via the infrmatin intermediary r device interface. The device interfaces that cllect and transmit measurement infrmatin t the infrmatin intermediary may include patient identificatin, device identificatin, and measurement details that may be needed by clinicians and care crdinatrs Event: Utilize device t btain measurements Actin: Patient utilizes the device t btain measurements as directed by his/her clinician r care crdinatr. The patient utilizes the device t btain measurements as directed. Sme devices (e.g. implanted devices, wearable patient mnitrs, etc.) may nt require a patient t actively take a measurement, as they are setup t take passive measurements at predetermined intervals r times Event: Transmit mnitring data frm device Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 24

28 Remte Mnitring Cde Descriptin Cmments Actin: Patient measurements are cmmunicated t the infrmatin intermediary. Patient measurements may be cmmunicated t the infrmatin intermediary upn patient initiatin r may ccur passively withut patient interventin based upn device. Sme devices may prvide the ability fr patients t prvide manual input as part f the measurement, either via the device directly r via a patient-fcused applicatin. The patient may access measurement infrmatin n the device directly, via a patientfcused applicatin assciated with the device. A patient may als receive and view remte mnitring infrmatin within the PHR via an infrmatin intermediary Event: Patient mdifies meds, dsage, activities, diet, etc Actin: Patient self-manages chrnic disease r wellness care based upn measurement values. The patient may mdify medicatin dsage (per clinician instructins), activities, diet, etc. based upn device measurement infrmatin and the care plan specified by the clinician Actin: The patient may be cntacted by a crdinatr t review r mdify care management activities. The patient may be cntacted by a care crdinatr t verify measurement data r discuss mdificatin f care management such as medicatin dsage (per clinician instructins), activities, diet, etc. The patient may be instructed t seek urgent/emergency care if apprpriate, r schedule a fllw-up appintment with a clinician respnsible fr his/her care Event: Patient discusses treatment plan with clinician Actin: Patient discusses treatment r management with their clinician. The patient is evaluated by their clinician and is prvided with an updated care plan Actin: Patient receives mdified treatment plan infrmatin frm a persnal clinician. The patient may electrnically access updated treatment plan infrmatin may be electrnically accessed thrugh the PHR as described in the Cnsumer Empwerment: Cnsumer Access t Clinical Infrmatin Use Case. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 25

29 Remte Mnitring Cde Descriptin Cmments Event: Patient implements mdified treatment plan Actin: Patient implements mdified treatment plan and cntinues remte mnitring participatin as directed. The patient implements the mdified treatment plan. Remte mnitring may cntinue as directed by the patient s clinician and/r care crdinatrs. The patient may cntinue t access measurement infrmatin n the device directly, via a patient-fcused applicatin assciated with the device, r via a PHR. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 26

30 Remte Mnitring 8.0 Infrmatin Exchange This sectin highlights selected infrmatin exchange capabilities which enable the scenaris described in this use case. These functinal capabilities may be prvided fully r partially by a variety f rganizatins including data intermediaries, free-standing r gegraphic health infrmatin exchanges (e.g. RHIOs), integrated care delivery netwrks, prvider rganizatins, health recrd banks, public health netwrks, specialty netwrks, and thers supprting these capabilities. Figure 8 1. Remte Mnitring Infrmatin Exchange Capabilities Cde Capability Cmments 8.1 Register device, patient and data recipient Capability t maintain infrmatin describing the remte mnitring device, the patient being mnitred and the individuals wh will be reviewing the mnitring data. Fr example, this may include registering the device with the manufacturer r data intermediary and perfrming ther functins t uniquely identify the individual being mnitred. 8.2 Data retrieval including data lkup, retrieval and data lcatin registries Capability t lcate and retrieve requested data subject t cnsumer access decisins and lcal plicies. The remte mnitring data is received via the infrmatin exchange and assciated with the apprpriate patient and data recipients. A clinician, care manager, r patient may access remte mnitring and clinical infrmatin directly via the infrmatin exchange using a prtal if available. 8.3 Data delivery including secure data delivery, cnfirmatin f delivery t EHRs, persnally cntrlled health recrds, ther systems and netwrks Capability t securely deliver data t the intended recipient, cnfirm delivery, including the ability t rute data based n message cntent if required. Fr example fllwing the care crdinatr s evaluatin f the remte mnitring data via the infrmatin exchange, mnitring infrmatin may be delivered t the apprpriate clinician s EHR r patient s persnally cntrlled health recrd. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 27

31 Remte Mnitring Cde Capability Cmments 8.4 Subject-data matching Capability t match available data t the apprpriate persn during retrieval r ruting. Fr example, when the clinician requests additinal clinical infrmatin fr a specific persn, the systems invlved in the infrmatin exchange cnfirm that the data available fr retrieval match the persn f interest t the clinician. While nt described in this sectin, ther capabilities which supprt infrmatin exchange include data integrity and nn-repudiatin checking; subject and user identity arbitratin with like identities during infrmatin exchanges; access lgging and errr handling fr data access and exchange; cnsumer review f disclsure and access lgs; and ruting cnsumer requests t crrect data. Device Data Intermediary: These entities prvide a direct device interface t btain, stre, and/r view measurement data cllected frm remte patient devices. In this rle, they can be bth a cnduit fr cmmunicating infrmatin t EHRs and PHRs and a surce f infrmatin that can be directly accessed by patients, family caregivers, care crdinatrs, and clinicians via an access-cntrlled user interface (e.g. web-based prtal, etc.). This stakehlder grup includes device manufacturers and ther third party entities that have develped device interfaces and assciated applicatins fr this purpse. Health infrmatin exchange (HIE): Fr the purpse f this use case, the functinal capability t exchange health infrmatin between netwrks in rder t exchange the health infrmatin f individuals r ppulatins. These functinal capabilities may be prvided fully r partially by a variety f rganizatins including free-standing r gegraphic health infrmatin exchanges (e.g. RHIOs), integrated care delivery netwrks, prvider rganizatins, health recrd banks, public health netwrks, specialty netwrks, and thers supprting these capabilities. Specialty Netwrk: may prvide all, r a prtin f the capabilities needed t accmplish the activities invlved in the exchange f health infrmatin. Specialty netwrks may fcus n the exchange f specific types f health infrmatin, may fcus n specific patient ppulatins, may fcus n the capabilities needed t supprt specific types f healthcare activities, r may perfrm a cmbinatin f infrmatin exchange activities and ther services. Pint-t-Pint Exchange: A direct link r cmmunicatin cnnectin with defined endpints. Office f the Natinal Crdinatr fr Health Infrmatin Technlgy 28