Prescription Flow

Description

Background

The FDA has strongly encouraged that the Tidepool Loop application be by prescription only With that, Tidepool has taken that advice and are providing a web portal for clinicians to prescribe and input initial settings for their patients.


Purpose

To mitigate safety concerns related to therapy settings in Tidepool Loop, the prescriber will be required to establish the patient’s initial settings when prescribing Tidepool Loop. Tidepool will take this opportunity to teach the clinicians about settings in Tidepool Loop. By requiring initial settings to be entered, the clinic staff has a forcing function to understand each of the settings used by Tidepool Loop, especially the two specific to Tidepool Loop (suspend threshold and insulin model) and those that exceed the function used in traditional pump therapy (correction range and maximum basal rate).

Our approach for the mechanism for delivery of prescription/care plan order is to enable prescriptions through a to-be-developed roles and permission system within Tidepool Web clinic access management. Tidepool will delegate the responsibility of managing prescriber privilege to a clinic administrator. We are currently discussing policy/procedure and terms to delegate responsibility to clinic to follow the procedure.

Each prescriber will be required to enter NPI number in their Tidepool account. Prescription order form will be completed under authentication in the Tidepool Web portal. Access codes will be sent after the prescription is confirmed by the prescriber. Method of delivery (email/text) of access code is being scoped now.

Product Strategy Document



The prescription prototype, on GitHub here (branch is rxFlow 3.0) is a react frontend JP/Daniel built. We may want to port over some (most) of the logic as well as UI.

Prescription data model

Business/Product Success Criteria

Clinicians are able to prescribe Tidepool Loop in a quick, intuitive way without disrupting their current prescription flow process.

XX prescriptions submitted within 90 days of launch.

Done Criteria

 

  • Prescription Form Submission: Prescriber is able to submit form for prescription via Tidepool Loop Prescription Form via Web Form or via faxed in prescription form

  • Tidepool generates a one time activation code for patient at prescription submission

Accessibility Specifications

None

Test Strategy

None

New Fields for Analytics/Export Configuration (if needed)

None

Activity

Show:
Janet Diehl
August 9, 2019, 10:10 PM
  • Decide on prescription anti-tamper security features (none? digital signature? checksum?) - depends somewhat on delivery method

  • Enable doctor to create a prescription (through TP Web?)

  • Enable doctor to send a prescription to PWD (via email? in-app? QR on TP Web?)

  • Enable doctor to rescind a prescription (is this needed? what happens if PWD already got it?)

  • Enable doctor to list issued prescriptions

  • Enable PWD to receive prescription within their Loop app (email? in-app? scan QR code?)

  • Enable PWD to review the prescription before accepting it

  • Audit log trail of prescriptions received & accepted in Loop

 

Janet Diehl
August 9, 2019, 10:10 PM

Janet Diehl updated the value for the Milestone custom field on this card

Mar 19 at 10:35 AM

Janet Diehl updated the value for the Milestone custom field on this card

Mar 14 at 9:26 AM

Tapani Otala added Epic Breakdown to this card

Mar 12 at 12:50 PM

Brandon Arbiter Jan 11 at 1:46 PM

@paulforgione2 : Our friends at Companion Medical have a very simple fax-in for getting started with InPen. Attached for inspiration.

Reply

Brandon Arbiter attached inpen-start-orders.pdf to this card Jan 11 at 1:45 PM

Reply

Brandon Arbiter joined this card

Nov 28, 2018 at 11:55 AM

Brandon Arbiter Nov 28, 2018 at 11:55 AM

  • Research, medical advisory committee

  • Leverage existing pump settings UI and data structures

Reply

Paul Forgione Nov 28, 2018 at 11:55 AM (edited)

Who can we talk to to find out what questions should be asked?
Answer from Howard: The Medical Advisory Committee

Reply - Delete

Brandon Arbiter moved this card from Development Tasks (Post 1.0) to Required to Ship

Nov 28, 2018 at 11:32 AM

Brandon Arbiter Nov 28, 2018 at 11:28 AM

Settings via fax machine code be OK.

Reply

Paul Forgione joined this card

Nov 28, 2018 at 11:23 AM

Pete Schwamb added this card to Development Tasks (Post 1.0)

Nov 14, 2018 at 10:35 AM

Janet Diehl
September 13, 2019, 5:37 PM

could you fill in the Bus Success criteria?

Amanda Jo Fisher
September 18, 2019, 7:01 PM

Notes from Trello Card: To use Tidepool Loop, the user will need an activation code that Tidepool provides after receiving a prescription from their doctor.

*Brainstorming*

Amanda Jo Fisher
September 18, 2019, 7:02 PM

More notes I don’t want to lose:

  • Determine how to process a prescription / validate the healthcare provider

  • Learn about having an Exemptee at Tidepool licensed by HMDR (Home Medical Device Retail Program)

  • Learn about Medical Device Manufacturer License from California Medical Device Branch

  • Doctor has a web form they can use to enter a prescription

  • Determine where the webform is hosted (e.g., rx.tidepool.org, or loop.tidepool.org/gettingstarted)

  • Doctor has a PDF form they can print and fax for prescription

  • Doctor has a PDF form they can email for prescription

  • User can send an email to their doctor with PDF form and link to online - submission

  • [Not a dependency for 1.0] Remote first time generation of Loop profile. Upon setting the prescription, the doctor or patient can enter user settings, either via the web form or in the PDF, which Tidepool will manually add. Those user settings submitted with the prescription are associated with the account and upon user activation of the prescription code in the mobile app, the settings are preloaded:

  • Suspend Threshold

  • Basal Rates

  • Max Basal

  • Max Bolus

  • Correction Targets

  • Workout Target

  • Pre-Meal target

  • Carb Ratios

  • Insulin Sensitivity Factors
    > The team was comfortable with doctor entry direct to the web form generated the patient settings. However, there is concern that receiving a fax and having Tidepool transcribe the settings from the fax into Tidepool might create unacceptable liability or additional work that's not required. One mitigation for the liability may be for a second person to double check everything, which indeed would be more work.

  • Let’s collect insurance information - may be useful when talking to insurers

Epic Name

Prescription Flow

Priority

Assignee

Unassigned

Reporter

Janet Diehl

Fix versions

None

Requested By (External)

None

Risk Level

None

User Experience Assessment Level

None

UEA: Issue Volume

None

UEA: Category

None

Components

None

Design Review Required?

None

Design Approved By:

None

Accessibility Review Required?

None

Accessibility Review Approved By

None

Approved for Production By:

None

Marketing Comms

None

Support Follow Up

None

KB Update

None

Pull Request Needed

None

Resolved Build #

None
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