Direct-to-Cloud-Constrained Devices - Detailed Proposal

1. Proposed Work Item: Direct-to-Cloud-Constrained Devices

• Proposal Editor: Michael J. Kirwan
• Proposal Contributors: Tim Frost, Thom Erickson, Horst Merkle, Erik Moll, Jacob Andersen, Barry Reinhold, Michael J. Kirwan
• Profile Editor: Tim Frost
• Profile Contributors: Thom Erickson, Horst Merkle, Tim Frost, Jacob Andersen, Erik Moll, Barry Reinhold, Michael J. Kirwan
• Domain: DEVices

Summary

To simplify and improve the remote patient monitoring user experience, it is desirable to enable medical sensor to communicate directly to a health server in the cloud. The use of a gateway device is not practical in many scenarios. The D2C solution leverages to the maximum extend practical existing industry standards covering cellular Internet of Things communications, IEEE Personal Health Devices, FHIR and transport security. Uniform implementation of these standards are essential to achieve interoperability. A simplified protocol is required to accommodate the compute and power limitations of such sensors. It is envisioned that the actors defined in the POU profile would be employed. However, the transactions would be materially different and therefore warrant a separate Implementation Guide. The COVID-19 pandemic has been the global defining event that has thrust remote patient monitoring into the minds of mainstream users. This IG will enable a collection of companies large and small from all corners of the globe to bring to market the billions of devices that must communicate universally understood health data critical to treating patients of pandemics. IHE Devices Domain expertise is uniquely suited to guide medical device manufacturers and Healthcare & Life Sciences software vendors leverage Patient Generated Health Data that is provided directly from a health sensor to health information system via cellular Internet of Things where WiFi may not be available.

2. The Problem

<Describe the integration problem: What doesn’t work, or what needs to work.>

<Now describe the Value Statement: what is the underlying cost incurred by the problem, what is to be gained by solving it. If possible provide quantifiable costs, or data to demonstrate the scale of the problem.>

3. Key Use Case

<Describe a short use case scenario from the user perspective. The use case should demonstrate the current integration/workflow problem. Consider a chonological bullet list of "A does X with Y".>

<Feel free to add a second use case scenario demonstrating how it “should” work. Try to show the people/systems involved, the tasks they are doing, the information they need, and hopefully where the information should come from.>

<Focus on the end user requirements, and not just the solution mechanism. Give concrete examples to help people trying to understand the problem and the nature of the solution required. Remember that other committee members reviewing the proposal may or may not have a detailed familiarity with this problem. Where appropriate, define terms.>

4. Standards & Systems

<List relevant standards, where possible giving current version numbers, level of support by system vendors, and references for obtaining detailed information.>

<List systems that could be involved/affected by the profile.>

5. Technical Approach

<This section describes the technical scope of the work and the proposed approach to solve the problems in the Use Cases. The Technical Committee will be responsible for the full design and may choose to take a different approach, but a sample design is a good indication of feasibility. The Technical Committee may revise/expand this section when doing the effort estimation.>

<If any context or "big picture" is needed to understand the transaction, actor and profile discussion below, that can be put here>

<If a phased approach would make sense indicate some logical phases. This may be because standards are evolving, because the problem is too big to solve at once, or because there are unknowns that won’t be resolved soon.>

<The material below also serves as the breakdown of tasks that the technical committee will use to estimate the effort required to design, review and implement the profile. It helps a lot if it is reasonably complete/realistic.>

<READ PROPOSER HOMEWORK IN Proposal Effort Evaluation FOR GUIDANCE ON POPULATING THE FOLLOWING SECTIONS >

Actors

• (NEW) <List possible new actors>
• <List existing actors that may be given requirements in the Profile.>

Transactions

• (NEW) <List possible new transactions (indicating what standards would likely be used for each. Transaction diagrams are very helpful here. Feel free to go into as much detail as seems useful.>
• <List existing transactions that may be used and which might need modification/extension.>

Profile

• <Describe the main new profile chunks that will need to be written.>
• <List existing profiles that may need to be modified.>

Decisions/Topics/Uncertainties

• <List key decisions that will need to be made, open issues, design problems, topics to discuss, and other potential areas of uncertainty>
• <Credibility point: A proposal for a profile with any degree of novelty should have items listed here. If there is nothing here, it is usually a sign that the proposal analysis and discussion has been incomplete.>

6. Support & Resources

<List groups that have expressed support for the proposal and resources that would be available to accomplish the tasks listed above.>

<Identify anyone who has indicated an interest in implementing/prototyping the Profile if it is published this cycle.>

7. Risks

<List real-world practical or political risks that could impede successfully fielding the profile.>

<Technical risks should be noted above under Uncertainties.>

8. Tech Cmte Evaluation

<The technical committee will use this area to record details of the effort estimation, etc.>

Effort Evaluation (as a % of Tech Cmte Bandwidth):

• xx% for MUE
• yy% for MUE + optional

Editor:

TBA

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