diff --git a/README.md b/README.md index b516784f..efbec006 100644 --- a/README.md +++ b/README.md @@ -61,6 +61,12 @@ SightAdapt processes window, process and executable information locally and stor Executable paths, settings, logs and screenshots can contain personal or confidential information. Redact them before publishing a support report and request a private channel from the repository owner before sending sensitive material. See the complete [privacy notice and support-data policy](PRIVACY.md). +## Intended purpose + +SightAdapt is general-purpose accessibility and display-personalization software. It is not intended to diagnose, treat, prevent, monitor or clinically alleviate any disease, injury or disability, and it is not a substitute for professional medical or eye-care advice. + +`Color correction` and `visual correction` refer to display presentation, not clinical vision correction. The project does not claim clinical effectiveness or target a named medical condition. See the controlled [intended-purpose and medical-device claims policy](docs/legal/INTENDED-PURPOSE-AND-MDR.md). + ## Build a standalone EXE The application can be published as a self-contained single-file executable. It does not need to be started with `dotnet run`, and the target computer does not need a separately installed .NET runtime. @@ -100,6 +106,7 @@ Create and validate the final archive according to [the binary packaging standar ## Documentation - [Product identity and brand usage](docs/BRAND.md) +- [Intended purpose and medical-device claims policy](docs/legal/INTENDED-PURPOSE-AND-MDR.md) - [Release naming and attribution](docs/RELEASING.md) - [Binary packaging standard](docs/PACKAGING.md) - [Complete functionality](docs/FEATURES.md) diff --git a/docs/BRAND.md b/docs/BRAND.md index 4a79f28a..01a73ca7 100644 --- a/docs/BRAND.md +++ b/docs/BRAND.md @@ -1,6 +1,6 @@ # SightAdapt™ product identity -This document is the source of truth for the public name, product descriptions, publisher attribution, trademark notation, and canonical links used by SightAdapt. +This document is the source of truth for the public name, product descriptions, publisher attribution, trademark notation, canonical links and controlled product claims used by SightAdapt. ## Canonical identity @@ -12,6 +12,8 @@ This document is the source of truth for the public name, product descriptions, | Product website | `https://aiteracja.pl/sightadapt/` | | Source repository | `https://github.com/KeyffMS/SightAdapt` | | License | `MIT License` | +| Intended purpose | General-purpose accessibility and display personalization | +| Medical purpose | Not intended | The product name is always written as `SightAdapt`, with a capital `S` and `A`, without a space or hyphen. Do not use `Sight Adapt`, `Sightadapt`, or `Sight-Adapt` as the product identity. @@ -42,7 +44,15 @@ Required public notice: > SightAdapt™ is a free, open-source visual-accessibility application for Windows 10 and Windows 11. It applies configurable color correction to selected application windows through a separate input-transparent overlay, supports saved profiles and per-application assignments, and provides an immediate emergency command to remove active overlays. SightAdapt does not modify another application's files or process memory and does not transmit captured screen content. -Descriptions may be shortened for strict character limits, but they must not introduce medical, clinical, universal-compatibility, or third-party-endorsement claims. +Descriptions may be shortened for strict character limits, but they must not introduce medical, clinical, universal-compatibility or third-party-endorsement claims. + +## Intended purpose and claims control + +SightAdapt is positioned as general-purpose accessibility and display-personalization software. It is not intended to diagnose, treat, prevent, monitor or clinically alleviate any disease, injury or disability, and it is not a substitute for professional medical or eye-care advice. + +`Correction` means display, color or visual-presentation correction. It must not be presented as clinical vision correction. Use `user`, not `patient`. Do not use product-controlled language implying therapy, treatment, diagnosis, clinical effectiveness, medically compensating for disability or suitability for a named condition. + +All website, README, release, store, directory, screenshot, support and social copy must follow [the intended-purpose and medical-device claims policy](legal/INTENDED-PURPOSE-AND-MDR.md). A disclaimer cannot be used to contradict an actual medical purpose communicated elsewhere. ## Publisher wording @@ -76,6 +86,7 @@ The GitHub repository is the canonical source-code URL: - Use the canonical one-line description immediately below the heading. - Link to the canonical product website and repository. - Include the required public notice in a brand or legal section. +- Keep claims within the approved general-purpose intended purpose. ### Application UI @@ -83,19 +94,22 @@ The GitHub repository is the canonical source-code URL: - Use `SightAdapt™` in the About dialog's prominent product-name label. - Display `Publisher: KeyffMS / aiteracja.pl`. - Link to the canonical website and source repository. +- Do not add clinical or condition-specific claims without renewed regulatory review. -### Releases +### Releases and stores - Release title: `SightAdapt™ `. - Tag and artifact names remain technical, for example `v0.5.0.50-alpha` and `SightAdapt-0.5.0.50-alpha-win-x64.zip`. - Begin release notes with the canonical one-line description. - Include the canonical product website, repository, publisher, license, and unregistered-mark notice. +- Do not select a medical-device category or target a named condition under the current positioning. ### Website - Use the supplied SVG lockup containing `™` for the most prominent identity. - Use plain `SightAdapt` in repetitive navigation and accessible names when that improves screen-reader output. - Use the canonical URL in canonical tags, structured data, sitemaps, downloads, and directory references. +- Review rendered copy, metadata, screenshots, testimonials and download descriptions against the intended-purpose policy before publication. ## Brand assets @@ -107,4 +121,4 @@ Do not stretch, skew, rotate, recolor, or remove the `™` notation from the sup ## Change control -Changes to the product name, canonical descriptions, publisher attribution, trademark notation, website URL, or primary brand assets must update this document first. Dependent README, UI, release, website, and directory text must be updated in the same change or tracked explicitly. +Changes to the product name, canonical descriptions, publisher attribution, intended purpose, medical positioning, trademark notation, website URL or primary brand assets must update this document first. Dependent README, UI, release, website, store and directory text must be updated in the same change or tracked explicitly. diff --git a/docs/README.md b/docs/README.md index 032d154e..306bb1bf 100644 --- a/docs/README.md +++ b/docs/README.md @@ -2,8 +2,9 @@ The documentation describes the current SightAdapt implementation and the canonical public product identity. -- [Product identity and brand usage](BRAND.md) — canonical name, `™` notation, descriptions, publisher attribution, website URL, and asset rules. -- [Release naming and attribution](RELEASING.md) — public release-title, tag, artifact, website, publisher, and mark conventions. +- [Product identity and brand usage](BRAND.md) — canonical name, `™` notation, descriptions, publisher attribution, intended purpose, website URL, and asset rules. +- [Intended purpose and medical-device claims policy](legal/INTENDED-PURPOSE-AND-MDR.md) — approved general-purpose positioning, prohibited medical claims, terminology, reviewed surfaces and renewed-assessment triggers. +- [Release naming and attribution](RELEASING.md) — public release-title, tag, artifact, website, publisher, store-claim and mark conventions. - [Binary packaging standard](PACKAGING.md) — required legal files, redistribution notice, SBOM, exact-version notices, archive validation and distribution-format rules. - [Microsoft .NET redistribution analysis](legal/DOTNET-REDISTRIBUTION.md) — Microsoft-origin component inventory, applicable terms, package implementation, review triggers and professional-review gate. - [Exact-version .NET notice generation](legal/DOTNET-NOTICE-GENERATION.md) — pinned SDK/runtime inputs, official package verification, notice import, checksums and update triggers. diff --git a/docs/RELEASING.md b/docs/RELEASING.md index c232eb84..86678370 100644 --- a/docs/RELEASING.md +++ b/docs/RELEASING.md @@ -1,6 +1,6 @@ # SightAdapt release naming -This document defines the public naming, attribution and minimum package-compliance rules for SightAdapt releases. +This document defines the public naming, attribution, intended-purpose and minimum package-compliance rules for SightAdapt releases. ## Public release identity @@ -34,6 +34,24 @@ Then identify: - publisher: `KeyffMS / aiteracja.pl`; - license: `MIT License`. +## Intended-purpose and store claims + +Release notes, store listings, directories, screenshots, metadata and support materials must follow [the intended-purpose and medical-device claims policy](legal/INTENDED-PURPOSE-AND-MDR.md). + +The current approved position is general-purpose accessibility and display-personalization software, not software intended for a medical purpose. Do not: + +- select a medical-device category; +- target a named disease, disorder, impairment or patient group; +- claim diagnosis, treatment, therapy, prevention, monitoring or clinical alleviation; +- describe display/color correction as clinical vision correction; +- claim clinical effectiveness or professional endorsement. + +Where a purpose clarification is appropriate, use: + +> SightAdapt is general-purpose accessibility and display-personalization software. It is not intended to diagnose, treat, prevent, monitor or clinically alleviate any disease, injury or disability, and it is not a substitute for professional medical or eye-care advice. + +A feature, category or marketing change that creates a potential medical purpose requires a new written assessment from a qualified EU medical-device regulatory professional before publication. + ## Required mark notice Include this notice once in the release description or linked legal material: @@ -50,17 +68,11 @@ Do not use `®`. - Link public website references to `https://aiteracja.pl/sightadapt/`. - Do not use `https://sightadapt.aiteracja.pl/` as a canonical URL; it is reserved as an optional redirect. - Use `Publisher`, not alternating `Author`, `Vendor`, or `Company`, on public release surfaces. -- Follow [the product identity standard](BRAND.md) for descriptions, attribution, and mark usage. +- Follow [the product identity standard](BRAND.md) for descriptions, attribution, mark usage and claims control. ## Binary release gate -Every binary distribution must comply with [the binary packaging standard](PACKAGING.md). The final archive or platform package must include the files listed in `release/required-files.txt`, including: - -- `LICENSE.txt`; -- `THIRD-PARTY-NOTICES.txt`; -- `DOTNET-LICENSE-NOTICE.txt`; -- `DEPENDENCIES.md`; -- `PRIVACY.md`. +Every binary distribution must comply with [the binary packaging standard](PACKAGING.md). The final archive or platform package must include every file listed in `release/required-files.txt`, including the license, exact-version notices, Microsoft redistribution notice, privacy notice, dependency inventory, SBOM and license report. The legal documents must be readable without starting the application. The final ZIP must pass: @@ -82,5 +94,7 @@ SightAdapt is a free, open-source Windows application for per-application visual - Publisher: KeyffMS / aiteracja.pl - License: MIT License +SightAdapt is general-purpose accessibility and display-personalization software. It is not intended to diagnose, treat, prevent, monitor or clinically alleviate any disease, injury or disability. + SightAdapt™ is an unregistered product mark used by KeyffMS / aiteracja.pl. ``` diff --git a/docs/legal/INTENDED-PURPOSE-AND-MDR.md b/docs/legal/INTENDED-PURPOSE-AND-MDR.md new file mode 100644 index 00000000..71d1989c --- /dev/null +++ b/docs/legal/INTENDED-PURPOSE-AND-MDR.md @@ -0,0 +1,127 @@ +# Intended purpose and medical-device claims policy + +## Decision record + +| Field | Reviewed value | +|---|---| +| Review date | 2026-07-29 | +| Product version | `0.5.0.50-alpha` | +| Publisher | KeyffMS / aiteracja.pl | +| Current positioning | General-purpose accessibility and display-personalization software | +| Medical purpose intended | No | +| Formal professional classification opinion | Not obtained; required before introducing medical claims or targeting diagnosed conditions | + +This document controls the current product positioning. It is a maintainer regulatory-risk decision, not a legal opinion or a professional medical-device classification assessment. + +## Regulatory basis considered + +Regulation (EU) 2017/745 distinguishes software specifically intended for a medical purpose from general-purpose software. Its definition of intended purpose includes the manufacturer's labels, instructions, promotional/sales materials and statements. The current review also considered European Commission guidance `MDCG 2019-11 rev.1`, published in June 2025, on qualification and classification of software. + +Authoritative sources: + +- https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 +- https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en + +## Approved intended purpose + +SightAdapt is general-purpose Windows accessibility and personalization software for people who choose to alter the visual presentation of selected application windows. + +Intended users are ordinary Windows users, including users who prefer different brightness, contrast, saturation, hue or color-inversion presentation. Use is self-directed in personal, educational or workplace computing environments on supported Windows computers. + +The software applies user-selected display transformations through a separate overlay. It stores per-application preferences and does not intentionally modify another application's files or process memory. + +SightAdapt is not intended to: + +- diagnose, prevent, monitor, predict, prognose, treat or alleviate a disease; +- diagnose, monitor, treat, alleviate or medically compensate for an injury or disability; +- measure visual function or determine a clinical state; +- recommend treatment, therapy, medication or clinical action; +- replace an examination, diagnosis, prescription or advice from a qualified professional; +- provide patient-specific clinical decision support; +- be used as part of a medical device or clinical workflow without a new assessment. + +The current product is therefore positioned as **general-purpose accessibility/display-personalization software, not software intended for a medical purpose**. + +## Approved non-medical statement + +Use this statement where a purpose clarification is appropriate: + +> SightAdapt is general-purpose accessibility and display-personalization software. It is not intended to diagnose, treat, prevent, monitor or clinically alleviate any disease, injury or disability, and it is not a substitute for professional medical or eye-care advice. + +The statement must not be used to contradict features, instructions or marketing that actually communicate a medical purpose. + +## Claims policy + +### Permitted descriptions + +Product-controlled materials may accurately describe: + +- per-application visual accessibility; +- display or color correction; +- user-selected brightness, contrast, saturation, hue and inversion settings; +- personalization of application-window presentation; +- saved profiles and assignments; +- technical behavior, privacy and limitations. + +### Prohibited without renewed assessment and evidence + +Do not claim or imply that SightAdapt: + +- diagnoses or detects a named condition; +- prevents, treats, cures, monitors or clinically alleviates a condition; +- restores, improves or corrects vision clinically; +- compensates medically for visual impairment or disability; +- has clinically proven effectiveness, sensitivity, specificity or therapeutic benefit; +- is prescribed, recommended or endorsed by healthcare professionals or authorities; +- is suitable for a patient, treatment plan, therapy or clinical workflow; +- can replace professional examination, treatment or assistive-device assessment. + +Testimonials, screenshots, search metadata, store categories and support answers must follow the same rule. A third party's statement must not be adopted or amplified by the project when it would create a medical claim. + +## Terminology rules + +| Term | Rule | +|---|---| +| `correction` | Use only for display, color or visual-presentation correction; never claim clinical vision correction. | +| `accessibility` | Permitted for general-purpose access and personalization. | +| `assistive` | Use cautiously and only in a general accessibility sense; do not describe SightAdapt as an assistive medical device. | +| `compensation` | Do not use for injury, disability or a medical condition without renewed classification review. | +| `patient` | Do not use for current users. Use `user`. | +| `therapy`, `treatment`, `clinical` | Prohibited as product-purpose or effectiveness claims for the current release. | +| named diagnoses or disorders | Do not target or claim outcomes for them without professional assessment and the required evidence. | + +## Materials reviewed + +The 2026-07-29 review covered: + +- repository `README.md` and documentation index; +- canonical descriptions and website rules in `docs/BRAND.md`; +- release/store-description rules in `docs/RELEASING.md`; +- implemented feature descriptions in `docs/FEATURES.md`; +- assembly description and About-dialog wording sourced through `ProductInfo.Tagline`; +- current About dialog fields (product identity, version, publisher, links and license); +- privacy, contribution and support materials; +- supplied brand screenshots/assets and current repository release materials. + +No product-controlled repository wording was identified that claims diagnosis, treatment, therapy or clinical effectiveness. The canonical product website URL is controlled by the same brand description policy. Before publishing or materially updating the external website or a store listing, the responsible publisher must manually compare the rendered text, screenshots, metadata and category selection against this document because external content may change outside the repository review. + +## Review triggers + +Obtain a new written classification assessment before merging, marketing or distributing a change that introduces any of the following: + +- targeting a named disease, disorder, impairment, injury or disability; +- patient, clinician, prescription, therapy or treatment workflows; +- medical or clinical effectiveness claims; +- measurements, tests, scores or recommendations about visual function or health; +- patient-specific analysis or clinical decision support; +- integration with a medical device, electronic health record or regulated clinical system; +- use of medical data to determine an output; +- marketing in a medical-device category, reimbursement pathway or healthcare procurement process; +- claims of medically compensating for a disability; +- a feature or marketing change that a qualified regulatory professional considers potentially medical. + +Before such a change, obtain a written assessment from a qualified EU medical-device regulatory professional and resolve any resulting MDR obligations. Record the reviewed version, materials, territories, professional role, date and non-confidential decision. Privileged or confidential advice remains outside the public repository. + +## Release gate + +Do not market SightAdapt for a named medical condition or claim medical, therapeutic or clinical outcomes until the professional classification assessment and any resulting regulatory obligations are complete. Current free distribution may use only the approved general-purpose positioning.