Panel · Use case · Innovation

DTx Launch Round Table.

LiveRound Table

Convene digital health, regulatory, HEOR and brand leads on how to launch a prescription digital therapeutic in the United States.

DecisionLaunch approach for a prescription digital therapeutic

DisciplinesDigital therapeutics, regulatory, HEOR, brand

ReaderDigital health and commercial leads

Not askedProduct design

DepthStandard, four seats

DTx Launch Round Table is a ready-made use case for Innovation. It ships under the Round Table template.

For digital health and commercial leads. You get each discipline's view in its own terms, where they connect and disagree, what none covered and what the deliberation does not settle. Claims are cited or marked as gaps.

Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.

The decision

How should a prescription digital therapeutic be launched in the United States?

Who is at the table

A prescription software product faces the usual launch questions plus a few of its own: how it is authorized, how it is prescribed and dispensed, and how a payer pays for software.

Seat	What it is asked	What it works from
Head of Digital Therapeutics	How clinicians will prescribe and monitor use, and what engagement the product needs to work.^{1Digital Therapeutics Alliance. Understanding DTx.}	The Digital Therapeutics Alliance’s definitions and clinical practice.
Regulatory Strategist	What the clearance allows the company to say and how updates to the software are handled.^{2U.S. Food and Drug Administration. Digital Health Center of Excellence.}	FDA’s device pathways and the product’s clearance.
HEOR Evidence Lead	What evidence a payer will ask for and how the German and French routes can inform the US case.^{3Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6.,4National Institute for Health and Care Excellence. Evidence standards framework (ESF) for digital health technologies.}	The DiGA directory and the NICE evidence framework.
Global Brand Lead	Who the first prescribers are and what message fits the clearance.	Market research and the clearance.

What the round table does

Authorization sets the message. What the company can say is bound by the clearance. The panel states the clearance and the claims it supports and marks any claim that goes past it.^{2U.S. Food and Drug Administration. Digital Health Center of Excellence.}

Reimbursement for software is unsettled in the US. The German directory shows one model with a fast track and a price negotiation. The panel treats it as an example and does not assume that the US will follow it.^{3Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6.}

Evidence tiers shape the plan. The NICE framework expects more evidence from software that treats than from software that informs. The panel uses it as a reference for what a payer is likely to ask.^{4National Institute for Health and Care Excellence. Evidence standards framework (ESF) for digital health technologies.}

Recommended length

Standard

Four disciplines bear on this question. Standard depth gives each a seat, with the table of connections and the dissent, in about four pages.

You can pick another length on the form. The other two stay available.

Assumptions the round table checks

The round table states the assumptions each seat relies on, and says what each gap limits. Examples for this question:

The product has FDA clearance or authorization for the indication to be launched.
Clinicians will prescribe software through existing workflows.
A payer will treat the product as a covered benefit or a device.

Standards, guidance and sources

Frame

Digital Therapeutics Alliance, Understanding DTx.^{1Digital Therapeutics Alliance. Understanding DTx.}
FDA, Digital Health Center of Excellence.^{2U.S. Food and Drug Administration. Digital Health Center of Excellence.}
BfArM, DiGA directory and fast-track process.^{3Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6.}
NICE, Evidence Standards Framework for digital health technologies.^{4National Institute for Health and Care Excellence. Evidence standards framework (ESF) for digital health technologies.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any claim that goes beyond the clearance, any assumption that a payer will cover software, and any reference to the German model as a US precedent.

What arrives

The question, and who was asked
Where the panel lands
What each discipline says
Where the disciplines connect
Where they disagree, and why it matters
What none of them covered
What changes, and what this does not cover

What it will not do

It is a deliberation of AI specialists and not a vote of human experts. It reports where they land and where they split, and the decision stays with you.

It does not advise on coverage or on the contents of a clearance.

It is not a vote of human experts. Every seat is an AI specialist, and the report says so.

It does not add a seat that did not speak or invent a quote or a number.

It does not decide. It sets out the views, the dissent and the gaps for you to decide.

References

[1] Digital Therapeutics Alliance. Understanding DTx. Read on 9 October 2026.
[2] U.S. Food and Drug Administration. Digital Health Center of Excellence. Known from search results; not read in full.
[3] Federal Institute for Drugs and Medical Devices (BfArM). Digital Health Applications (DiGA): Interesting facts. DiGA Guide version 3.6. Read on 9 October 2026.
[4] National Institute for Health and Care Excellence. Evidence standards framework (ESF) for digital health technologies. Not read in full.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

About the Panel service

Each panelist answers in their own voice, then the discussion is drawn together. You get the question and who was in the room, every position in full, what they agreed on, where they split, and what follows. Disagreements are written down rather than smoothed into a consensus nobody actually holds, because the split is usually the part you needed.

To edit a saved template, open New → Panel → From template, or the library rail on the service form.