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Overview & Rationale

The impetus for this white paper, "Accelerating Safe, Effective and Secure Remote Monitoring and Mobile Health Interoperable Solutions", was born out of the global COVID-19 pandemic challenge and the need to accelerate the implementation and use of interoperable remote monitoring and mobile health technologies, but at the same time to ensure open standards-based interoperability as well as assess whether the rapid response being proposed is sufficiently safe and secure and effective - that is, it will actually perform as intended when it is needed!  The paper answers questions such as:

  • What informatics standards should be considered when developing remote monitoring / mHealth solutions?
  • What safety, effectiveness & security (SES) standards should be leveraged to balance solution options with risk-based public good assessments?
  • How can application of these standards be scaled in crisis situations where resources and time are highly constrained? 
  • ...

This white paper proposal(ISOTC215 WG2 PWI, May 2020) was developed with strong facilitation by Konstantinos Makrodimitris, Ph.D. (US FDA/DHHS liaison to TC215 WG2), as well as a small team of subject matter experts:

Todd Cooper
Gora Datta
Ken Fuchs
John Rhoads

The following "quad chart" captures the key elements of the proposal (this is "living" quad-chart and subject to revision as the project evolves):

And the following presentation by Dr. Makrodimitris provides additional background and intended content for the white paper:

Note that this white paper is also closely related to the more general Gemini SES MDI white paper project.


What Lays Below ...

Content Considerations

<issues / topics / questions to be considered ... leads into the white paper section below>

<Scope>


Roadmap & Team Collaboration

White Paper Roadmap

  1. Develop a joint HL7-IHE Gemini White Paper 
    • Balloted white paper that is approved and jointly published in both organizations
    • Home working groups:  IHE Devices (DPI) and HL7 Devices (DoF)
    • Supporting working groups:  IHE DEV (PCH & PCD);  HL7 Mobile Health & ISO/TC215 WG#2
    • TARGET:  Ballot 2020 Q3/Q4
  2. ISO/TC 215 Coordination
    • Add a preliminary work item (PWI) to the WG2 and JWG7 program;  update TC215 CAG2 appropriately
    • Invite international expert participation in the Gemini white paper development 
    • Once the white paper is completed in the HL7-IHE Gemini Project, it will be submitted for "fast track" processing via the IHE International Liaison A track to ISO/TC 215.  
    • Since the white paper may include recommendations for further work in WG2 and JWG7, ensure that it is a topic to be included in the WG2 & JWG7 meetings later in 2020
    • TARGET:  PWIs by 2020 July; participation invitations starting 2020 May; white paper fast track before end 2020

Development Status

  1. IHE Devices
    • Work item approved at the monthly DEV meeting 2020.05.27
  2. HL7 Devices
    • PSS Proposal to be submitted by Friday, 2020.05.22 
    • NOTE:  Plan is a single PSS for all three Gemini SDPi+FHIR white paper proposals, followed by a single PSS Form
  3. ISO/TC 215 
    • WG2 PWI approved in virtual meeting 2020.05.18; TC confirmation of resolution - APPROVED July 1, 2020
    • JWG7 PWI to be proposed in virtual meeting 2020.06.03 (to be confirmed)
    • Note:  CAG2 will review and determine best "home" for the work (i.e., WG2 or JWG7); JWG7 would require confirmation from the other parent committee IEC/SC 62A
  4. Gemini Project Coordination
    • Proposal reviewed at the 2020.05.19 Steering Committee meeting
    • TBD process & IP details on how and where to jointly publish a Gemini white paper

Paper Team Participants

The following individuals have requested to be included in the Quiet Hospital Team:

Also these individuals/experts will join for input in specific sessions:

  • Orlando Lopez NIH
  • Andrea Coravos CEO, digital health sector
  • Larry Callahan FDA ISO
  • Brian Fitzgerald FDA standards 


NOTE:  Team participants who are also registered HL7 Confluence users  be able to comment and add content.

SES MDI Team Discussion Notes


 Gemini SDPi+FHIR SES MDI Remote Monitoring / Mobile Health White Paper Team Discussion Notes
 2020-06-02 Tuesday Web Meeting

Agenda

  1. Reviewed status of SES MDI RM / MH white paper project approval and development 
  2. Planning for white paper content development
  3. New Business

Participants

Konstantinos Makrodimitris John Rhoads Gora Datta Todd Cooper

Meeting Notes

  1. General Status Review & Backgrounder (All)
    1. Review of white paper project approvals (IHE & HL7 & TC215)
  2. Development Planning (All)
    1. Starting next Tuesday (2020.06.09) begin 1 hour weekly work sessions; use IHE DEV WebEx; 
    2. Create Project Team list on this page
    3. Include web meeting notes on this page


 2020-06-09 Tuesday Web Meeting

Agenda

  1. General Updates on White Paper Development & Standards Coordination &  Community Engagement
  2. Content Review and Development Planning
  3. New Business

Participants

Todd Cooper Gora Datta Konstantinos Makrodimitris Kenneth Fuchs

Axel Wirth 

Meeting Notes

  1. Reviewed Status / Confluence Page Content
    1. Kosta reviewed some of the objectives from the quad-chart (above)
  2. (Gora) Reviewed "Remote Mobile Health" graphic
    1. CURRENT Iteration (Work in Progress!):
    2. NOTES:
      1. Standards inside red circle are representative and not limited to the scope of the particular quadrants that they overlay
  3. Security Perspectives - Axel
    1. First-Call Introduction - Provided professional & current background (see LinkedIn for specifics).
    2. Current PROCESS FOCUSED approach:   3 Disclosure Pillars
      1. What's supported?  (SBoM / MDS2)
      2. What's the vulnerabilities?
      3. Deployment of vulnerabilities mitigation (patches)
    3. Security needs to be "nimble" because the attacks are dynamic - must have a pragmatic technology approach to reduce the reliance on process (b) above
      1. You can never patch enough to be secure enough ...
      2. In a crisis response "you go to war with the security you have" 
      3. Consider:  Stockpiling med tech is important (think ventilators ready to go) - but is their security provisions maintained and ready for use?
  4. Remote Monitoring Scenarios  / Variations - Ken
    1. Reviewed a slide with some alternatives for consideration (Work In Progress):
       
    2. Limited to monitoring?  Or also therapies / treatment?  (e.g., home dialysis) 
      1. For example, you may be sending COVID-19 patients home from hospital ASAP but need to monitor and "remote" treatments 
      2. Chronic patients may also have an elevated need for RM/MH given their existing frailty / vulnerability
    3. Consider also visiting nurses, nurse support, etc. vs. simple person / family care giver support
    4. Add "Where is the clinician or nurse?"  as another dimension 
  5. NEXT WEEK:  
    1. Consider converting the diagram / model & "Variations" above into a table that can be used to capture various dimensions
    2. Gora will provide a briefing on primary care remote care to patients (now almost 100%!)


 2020-06-16 Tuesday Web Meeting

Agenda

  1. General Updates on White Paper Development & Standards Coordination &  Community Engagement
  2. Topics:
    1. (Ken) Variations expanded w/ table representation
    2. (Gora) Briefing on primary care's use of RM/MH for most "visits" today
  3. Document Outline Review
  4. New Business

Participants

Todd Cooper Kenneth Fuchs Gora Datta Konstantinos Makrodimitris John Rhoads

Axel Wirth

Meeting Notes

  1. General Updates
    1. Updated on changes to SES RM/MH 
    2. ACTION: (Kosta) Invite Greg Zeller & John Garguilo 
  2. Topic:  Review RM/MH Continuum Slides (Ken)
    1. Discussed the slides "Remote" Monitoring - Continuum 
    2. Considered overlaying 4 quadrants diag (above) with the Continuum w/ "Time to Respond" vs. "Acuity" axes;  
    3. Factor in geographies (implicitly / explicitly):  Urban, Suburban, rural etc. + Underserved communities
    4. Factor in advanced identification of long-term acute individuals (e.g., on a ventilator at home) - and taking early action to prevent severe impact 
      1. For example, often patients on vents self-position in / at an ER just in case the power goes out in a hurricane and they don't want to run the risk
    5. PURPOSE:  Understand the meaning of RM - organizing current segments - in a model that can help organize the SES RM/MH guidance & strategy below 
    6. NOTE:  Discussed RM w.r.t. Bakul's AAMI Digital Health webinar yesterday 
    7. ACTION (Ken) provide an updated version of the diagram + tabular rendering 
    8. ACTION (Kosta / Gora) See if there is a nomenclature for these areas already + vet with clinical experts 
      1. Example CMS Place of Service Codes
  3. Topic:  Real-world data that can be captured from RM/MH ... especially in crisis response
    1. ACTION (Todd) add this topic as a place holder in the white paper outline below


Action Items / Task Lists

  • Todd CooperCraft sub-pages for the various sections
  • Kenneth Fuchs Update "remote monitoring" graphic and table per discussion last week
  • Konstantinos Makrodimitris Invite additional participants:  John Garguilo, Dr. Gregory Zeller, Orlando Lopez, 
  • Kenneth Fuchs Update graphic & tabular version 
  • Gora Datta Nomenclature defined somewhere for these care contexts?  e.g., ATA or SNOMED etc.
  • Konstantinos Makrodimitris Engage some internal clinicians to review slides
  • Todd Cooper Finish migrating content from proposal slides + use of real-world evidence collection topic place holder


 2020-06-23 Tuesday Web Meeting

Agenda

  1. General Updates on White Paper Development & Standards Coordination &  Community Engagement
  2. Topics:
    1. ...
  3. Document Outline Review
  4. New Business

Participants

Konstantinos Makrodimitris Todd Cooper Gora Datta Kenneth Fuchs John Rhoads John J. Garguilo

Axel Wirth, Greg Zeller, 

Meeting Notes

  1. Introductions:  Greg Zeller joined the team
  2. Review of AAMI FDA Digital Health Webinar
    1. Gora & Kosta reviewed the slide deck from Bakul  in the FDA for AAMI webinar last week
    2. Very little standards coordination or international coordination of Digital Health initiative 
    3. Given the international standards activity in digital health and devices .
  3. Review of the IMDRF SaMD Guidance
    1. Kosta reviewed the IMDRF SaMD Guidance document 
    2. Includes discussion around mobile SaMD apps
    3. This is an opportunity to engage FDA CDRH via the IMDRF guidance ... 
  4. Reviewed the Remote Monitoring classification slides
    1. Ken reviewed his updated slide w.r.t. remote monitoring "contexts" nomenclature 
    2. Slide #54 includes U.S. CMS Nomenclature for "Places of (Healthcare) Service" 
      1. These are required for CMS submissions for care delivery claims
      2. NOTE:  #02 is Telehealth facility ... patient goes to specialized telehealth facility and is "remote" - physician is in his office 

 

    1. Note:  Consider Remote Care vs. Remote Monitoring
      1. (Axel) Does "care" include treatment?  Diagnosis?
      2. Focus on remote care functions/dimensions: Connectivity Displaying Transmitting Reporting Alerting Controlling Analyzing Diagnosing...others?
      3. Treating is probably an extreme remote care scenario although it can happen:  remote surgery, robotic assisted surgery, teledentistry/orthodontics, AI devices in future etc
    2. Characterizing Remote Care Contexts:
      1. Where is the patient?
      2. Where is the clinician?  Visiting Nurse?  Coaching?  
      3. What is the acuity?  (risk analytics / risk classification / stratification )
      4. What is the morbidity / morbidities?
      5. Health and wellness monitoring requirements?
      6. ... 
    3. NOTE:  SES MDI Risk Assessment guidelines is predicated on (d) above, then across the Key Properties 
      1. What are the Quality of Information / Data ... Quality of Service ... etc. requirements 
      2. Can "remote care" DECISIONS be made on the data received?
      3. Analogous to Patient Reported Outcomes
  1. U.S. HHS Hearings Energy & Commerce Committee including "telemedicine" update with COVID-19
    1. TODAY's hearings included statements:
      • Coronavirus pandemic has highlighted importance of telemedicine, top doctors say From CNN's Amanda Watts Top doctors told the House Energy and Commerce Committee today that telemedicine has been instrumental during the Covid-19 pandemic – and they hope it is here to stay. “Telemedicine is a very important component… as we look forward in the future, I think you're going to see a lot more of that,” Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, told a House hearing today. Admiral Dr. Brett Giroir, assistant secretary for health at US Department of Health and Human Services, said with a huge increase of virtual visits, the US has “learned tremendous lessons about the utility of telemedicine.”
      • “Just to understand the uptake — the week of Jan. 15 there are only 500 telehealth visits by Medicare, the week of April 15, there was 150,000 of them,” Giroir said at the same hearing. Dr. Robert Redfield, director of the US Centers for Disease Control and Prevention, said it is very important to get the health system back up and running as soon as possible. “The introduction of telemedicine is a critical component, something that needs to stay as part of the innovation, as we work more and more to move from a disease based system to a health system,” Redfield said.


 2020-06-30 Tuesday Web Meeting

Agenda

  1. General Updates on White Paper Development & Standards Coordination &  Community Engagement
  2. Topics:
    1. ...
  3. Document Outline Review
  4. New Business

Participants

Kenneth Fuchs Todd Cooper Konstantinos Makrodimitris John Rhoads Gora Datta

Axel Wirth

Meeting Notes

  1. WP Title Discussion
    1. Should the title be modified to include "remote CONNECTED care"? 
    2. Gora researched use of the phrase "connected care":
      1. Is increasingly used in the market place, BUT
      2. Not aligned with a specific company or organization
      3. the phrase "remote connected care" not used anywhere at this point
      4. ACTION(Gora) add emailed research links to this confluence page
    3. Does this also require understanding / addressing non-connected care?
      1. For example, visiting nurse or someone calling the patient w/o "connected" component
      2. Non-connected care will increasingly not be viable because who 
      3. Address this topic as part of the white paper content
    4. Ken - consider "remote monitored care"
      1. Vs. actual treatment vs. monitoring 
      2. treatment is definitely increasingly in future systems and should be addressed in the white paper
    5. Axel remote treatment monitoring vs. delivery?
      1. White paper would address the topic but then identify what is near / further term
      2. See Remote Care / Remote Monitoring topic in previous meeting 
      3. See references below
  2. Definitions 
    1. Remote = not face-to-face
      1. NOTE:  On the  patient side of "remote" there may be a non-skilled / limited skilled caregiver "locally" working with remote clinician
      2. For example, SNF or "remote consult" 
      3. See Remote Health graphic above
      4. ACTION (Gora) Update the Remote Mobile Health graphic above
    2. Connected = digital information flow bi-directionally, sync and non-sync between patient & provider
    3. Care = Includes both "diagnosis & treatment "
      1. D&T is the regulatory medical meaning of this phrase
      2. This includes:  observation, intervention, detection, ...
  3. Topic: Digital Health
    1. Include as a core topic in the white paper
  4. Potential Remote Connected Care Locations
    1. Ken updated the discussion slides ...
    2. Ken will work with Gora to finalize version of the graphics ... 
  5. ETSI IoT Security for Consumer Devices 
    1. Axel discussed the ETSI IoT standard (ETSI EN 303 645)
    2. Includes 13 criteria for personal health device for inclusion in scope of standard 
      1. No universal default passwords
      2. Implement a means to manage reports of vulnerabilities
      3. Keep software updated
      4. Securely store sensitive security parameters
      5. Communicate securely
      6. Minimize exposed attack surfaces
      7. Ensure software integrity
      8. Ensure that personal data is secure
      9. Make systems resilient to outages
      10. Examine system telemetry data
      11. Make it easy for users to delete user data
      12. Make installation and maintenance of devices easy
      13. Validate input data
    3. Consider reference and discussion in white paper
  6. Remote Treatment References
    1. https://www.businessinsider.com/5g-surgery-could-transform-healthcare-industry-2019-8
    2. https://pubmed.ncbi.nlm.nih.gov/27782591/
    3. https://www.kidney.org/atoz/content/homehemo
    4. https://fmcna.com/news/news-releases/patienthub-connected-health-platform-linked-to-improved-clinical/
  7. Document Organization Discussion
    1. How to formalize document on these confluence pages
    2. How to publish the white paper while keeping the dynamic content here (or similar)
    3. To be discussed in more detail next week


Action Items / Task Lists


 2020-07-07 Tuesday Web Meeting

Agenda

  1. General Updates on White Paper Development & Standards Coordination &  Community Engagement
  2. Topics:
    1. Editorial Planning (Kosta/Ken UPDATE) 5mins
    2. Roadmap this summer-fall for the white paper (potential milestone 12-14 weeks) 20mins
      1. specific sessions (clinicians/cases, security, clinical trials/EHR & interop, NIH research/proposals, )
      2. focus on home use? Human factors expert, patient/consumer perspective, mobile phones and apps landscape
      3. senior population high risks case and story/geriatrics
      4. Medical Device data/parameter and sensors need to interop with other data and algorithms(labs, AI, risk scores, drug medications...)
    3. IEEE P2933 - Discussion for how to "integrate" 10mins
  3. Document Outline & Content Discussion
  4. New Business

Participants

Konstantinos Makrodimitris Gora Datta John Rhoads Todd Cooper Kenneth Fuchs Paul Schluter John J. Garguilo

Dr. Greg Pappas, Axel Wirth

Meeting Notes

  1. General Updastes
    1. Dr. Greg Pappas - first meeting; public health physician at FDA;  focused on RWE and the challenges around interoperability 
    2. Dr. Paul Schluter - retired from GE, but continuing focus on medical device informatics standardization, especially around terminology / nomenclature
    3. Reviewed Agenda
  2. Editorial Planning
    1. Kosta asked Ken to be General Editor - still waiting for final Dräger approval to take on this role, but will accept in the interim 
    2. Call for Co-Editors?
      1. Gora volunteered as a Contributing Editor
    3. Roadmap Discussion
      1. Time frame
        1. ISO/TC215 WG2 is a PWI - Meaning the clock has not started; we will report out during the October meetings, at which point we can 
        2. In IHE and HL7, we can go as fast or short as appropriate
        3. NOTE:  Important to constrain the time to a few months to keep the document content "tight" 
      2. Outline / Topics
        1. (Pappas) Subject Matter Context:  How this work connects with other related activities (e.g., to Logica Roadmap)
        2. (Pappas) Use Cases & Value Propositions - establishing relevance and benefits based on the challenges being addressed 
        3. (Kosta) Pharma - looking for how to integrate device-sourced information during clinical trials 
      3. Web Discussion Sessions
        1. (Kosta) Security (Axel & Fitzgerald)
        2. Semantic (Schluter)
        3. Clinical Cases (Pappas and Goldman)
        4. Others ....
      4. Core Care Context Foci
        1. Home health context
        2. ICU - Remote Viewing of Patient 
      5. <see Agenda (2.b) above>
  3. "Where's Waldo?" (the patient) Discussion
    1. Ken presented updated slides mapping out perspectives on patients, providers, care contexts, etc.
    2. Expanded sequence of slides to show the different layers and connections of the topics within this area
    3. (Kosta) Need to capture use cases that can be used to define and chart the dynamics across these models
    4. (Todd) The intersection of these models + use cases could significantly improve the productivity / value of focused discussions (mentioned above)
    5. (Kosta) Need to include a focus on the intersection between med tech "trials" and the integration / leveraging of RWE & aggregated data
    6. (Ken) these diagrams focus more on where the patient is vs. where / how the "connected" care monitoring / information systems live and network
  4. IEEE P2933 - Discussion for how to "integrate" 
    1. Ken provided an overview of the project
    2. Showed the project Scope diagram
    3. Reviewed some of the Clinical Narratives
      1. #1:  Managing Glucose Levels
      2. #2:  Farm to Table
      3. ...
    4. Ken reviewed the scenario "brainstorming" approach (Rosebud analogy)
    5. Kosta mentioned that Orlando also mentioned this team reporting to the P2933 group
  5. Next Week
    1. Discuss 2015 paper on different remote ICU monitoring approaches from GE and Philips 
    2. ...


Action Items / Task Lists

No new action items.


 2020-07-14 Tuesday Web Meeting

Agenda

  1. Agenda Review / Introductions / General Updates

Participants

<confluence participants>

<non-confluence participants)

Meeting Notes

  1. ...

Action Items / Task Lists


Other related web meeting discussion notes are captured on the SDPi+FHIR Meeting Logs & Notes page.


 Gemini SES RM/MH White Paper Tasks Report

DescriptionDue dateAssigneeTask appears on
07 Jul 2020Kenneth FuchsPaper: SES Remote Connected Care and Mobile Health
  • Gora DattaUpdate the Remote Mobile Health graphic above
Gora DattaPaper: SES Remote Connected Care and Mobile Health
  • Gora Datta add emailed research links to this confluence page 
Gora DattaPaper: SES Remote Connected Care and Mobile Health
Konstantinos MakrodimitrisPaper: SES Remote Connected Care and Mobile Health
Konstantinos MakrodimitrisPaper: SES Remote Connected Care and Mobile Health
  • Todd Cooper Finish migrating content from proposal slides + use of real-world evidence collection topic place holder
Todd CooperPaper: SES Remote Connected Care and Mobile Health
Kenneth FuchsPaper: SES Remote Connected Care and Mobile Health
  • Gora Datta Nomenclature defined somewhere for these care contexts?  e.g., ATA or SNOMED etc.
Gora DattaPaper: SES Remote Connected Care and Mobile Health
  • Kenneth Fuchs Update "remote monitoring" graphic and table per discussion last week
Kenneth FuchsPaper: SES Remote Connected Care and Mobile Health
Todd CooperPaper: SES Remote Connected Care and Mobile Health




"Accelerating Safe, Effective and Secure Remote Connected Care and Mobile Health Interoperable SolutionsWhite Paper

This section contains the content of the white paper.  Outline sections can be started here and then linked to subpages as content gets developed.

Title:           "Accelerating Safe, Effective and Secure Remote Connected Care and Mobile Health Interoperable Solutions"

Subtitle:     "Addressing the immediate and future needs and gaps exposed by the Pandemic focusing on:in-patient, outpatient, post-acute-care & patient home care scenarios"

Executive Overview

<summarize / bullet anticipated content here>

Scope & Organization

Introduction

<.... sections ...>

Definitions / Glossary (annex)

<especially references to standards / literature> 

<consider this section here OR a glossary annex>

RM/MH Architectural Perspectives 

<types of RM ... scenarios ...>

diagnosis / treatment / monitoring 

Safe Effective & Secure

<what do we mean by SES>

<standards & framework to be leveraged>

Accelerating SES in a Rapid Response to Crisis 

Considerations for pragmatically establishing an understanding of SES over RM/MH architectures 

Recommendations for Further Standardization

IHE-HL7?  ISO/IEC JWG7?  IEEE?  Etc.

<... annexes ...>

Bibliography