Panel · Use case · Innovation

Digital Therapeutic Software Risk.

LiveBenefit-Risk Panel

The clinical benefit is shown, but the software carries its own risks. Is the net balance acceptable and under what controls?

DecisionWhether the net balance is acceptable and under what controls

FunctionsDigital therapeutics, quality, regulatory, operations

ReaderDigital health and quality leads

Not askedA software redesign

DepthStandard, four seats

Digital Therapeutic Software Risk is a ready-made use case for Innovation. It ships under the Benefit-Risk Panel template.

For innovation leads. You get the effects table, each seat's conclusion, the weighing matrix, the uncertainties and the risk-minimisation measures. Claims are cited or marked as gaps.

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The decision

The clinical benefit of a digital therapeutic is shown, but the software carries its own risks. Is the net balance acceptable and under what controls?

Who weighs

For a medical device, FDA has its own guidance on the factors to consider in benefit-risk determinations, and ISO 14971 sets the risk management process. The seats weigh software risks, such as errors and data loss, with the clinical benefit.

Seat	What it weighs	What it works from
Head of Digital Therapeutics	The size of the clinical benefit and what depends on engagement.	Trial evidence.
Director Quality Assurance	Software risks: errors, updates, cybersecurity and data integrity, and the controls.^{2International Organization for Standardization. ISO 14971:2019, Medical devices: Application of risk management to medical devices.}	ISO 14971 risk management.
Regulatory Strategist	How the balance would be judged for the device pathway.^{1U.S. Food and Drug Administration. Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: guidance for industry and FDA staff.}	FDA’s device benefit-risk guidance.
Clinical Operations Director	What the clinical studies showed about harms in use.	Study reports.

What the assessment does

Two kinds of risk. The effects table separates risks from the treatment effect, such as missed alerts, from risks of the software, such as a failed update. Each has its own controls.^{1U.S. Food and Drug Administration. Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: guidance for industry and FDA staff.,2International Organization for Standardization. ISO 14971:2019, Medical devices: Application of risk management to medical devices.}

Controls are part of the balance. The risk minimization table states which controls are in place, who owns them and how their effectiveness is judged.^{2International Organization for Standardization. ISO 14971:2019, Medical devices: Application of risk management to medical devices.}

Engagement affects benefit. Benefit may depend on how much patients use the software. The report states what the data show about that.

Recommended length

Standard

Four functions read the effects differently. Standard depth gives each a seat and shows the weighing matrix and the risk minimization table in about four pages.

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

Assumptions the assessment makes

The assessment states what it assumes about the evidence and the setting, and says what each gap limits. Examples for this decision:

Software updates are controlled so that benefit is not degraded.
Users will keep to the instructions.
Cybersecurity threats are monitored.

Standards, guidance and sources

Frame

FDA, factors to consider when making benefit-risk determinations for medical devices.^{1U.S. Food and Drug Administration. Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: guidance for industry and FDA staff.}
ISO 14971, application of risk management to medical devices.^{2International Organization for Standardization. ISO 14971:2019, Medical devices: Application of risk management to medical devices.}

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

What gets flagged

Any software risk with no stated control, any benefit claim that assumes high engagement without data, and any update risk not covered by change control.

What arrives

Decision and therapeutic context
Benefit-risk conclusion
Effects table
What each seat concludes
Weighing matrix by seat and criterion
Uncertainties and sensitivity
Risk minimisation and monitoring
What would change the balance

What it will not do

It does not replace a regulator or a benefit-risk committee. The conclusion is analyst judgment from AI specialists, and the decision stays with you.

It does not validate the software or assess its security.

It does not replace a regulator or a benefit-risk committee. The conclusion is analyst judgment from AI specialists.

It does not compute a single benefit-risk score or invent patient preferences.

It does not add an effect that no source supports. Missing data are marked as gaps.

References

[1] U.S. Food and Drug Administration. Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: guidance for industry and FDA staff. Title known from FDA’s guidance listing; not read.
[2] International Organization for Standardization. ISO 14971:2019, Medical devices: Application of risk management to medical devices. Known from the ISO catalogue; the standard is paid and was not read.

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.

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