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Pocket Genes

Science

Regulatory and Intended-Use Statement

States what Pocket Genes is intended to do, who it is for, where it is used, and the product scope.

Purpose and scope

This statement describes the intended users, environment, functions, and scope of Pocket Genes. It helps users, providers, organizations, and reviewers understand what Pocket Genes is designed to do.

Availability, legal classification, and regulatory obligations may vary by region and by product functionality. Pocket Genes should review this statement before launching materially different clinical, diagnostic, research, or decision-support functionality.

Who this statement applies to

  • Adults receiving or accessing genetic reports.
  • Parents, guardians, caregivers, family members, and learners using authorized workflows.
  • Professionals and organizations using Pocket Genes as an access, education, or engagement tool.
  • Providers or integrators that make reports or resources available through Pocket Genes.

Definitions

Intended use

The purpose and context for which Pocket Genes is designed, described, and offered.

Intended user

The person or organization expected to use Pocket Genes for the stated purpose.

Provider responsibility

The provider role in testing, issuing reports, determining findings, and answering report-specific clinical questions.

Education and engagement

General information, organization, resources, community, and preparation tools that help users understand concepts and next steps.

Intended environment

Pocket Genes is a mobile-centered consumer and patient engagement, education, access, discovery, and community platform. Laboratory, electronic-health-record, emergency, diagnostic, and clinical-monitoring functions remain with the dedicated provider systems that perform those roles.

Intended functions

  • Help authorized users access provider-made reports or provider-connected report experiences.
  • Organize access paths, report references, educational context, and related resources.
  • Provide general education about genetic terminology and concepts.
  • Help users discover organizations, events, resources, and education updates.
  • Support optional RareFriends community participation.
  • Help users prepare questions for qualified professionals.

Provider responsibility

Providers perform testing, issue reports, determine report findings, control provider resources, and remain responsible for report accuracy and report-specific clinical interpretation.

Questions about result validity, variant classification, pathogenicity, diagnostic meaning, family implications, treatment, screening, or clinical actionability should be directed to the report provider or another qualified professional.

Product scope

  • Genetic testing and laboratory results remain with qualified providers or laboratories.
  • Variant classification, pathogenicity, and clinical actionability remain source-provided unless a specific qualified source supplies that information.
  • Diagnosis, treatment, emergency monitoring, crisis response, and urgent clinical triage remain with qualified professionals and emergency services.
  • Third-party resources, organizations, events, and community answers should be reviewed in each user personal context.
  • Professional medical, genetic, legal, or psychosocial advice remains with qualified professionals.

Community and third-party scope

Peer experience, community posts, organization content, and event information should be treated as general context. Trusted Organization status is a review signal for participation standards, not a clinical endorsement of every service or claim.

External provider resources may have separate terms, privacy notices, accessibility limits, support channels, and availability constraints. They may become unavailable independently of Pocket Genes.

Children and caregivers

Children, minors, and people who need assistance should use Pocket Genes through a parent, guardian, caregiver, provider, or authorized representative where required. Caregiver-managed use must respect the authority, privacy, and best-interest obligations that apply to the person whose information is managed.

Geographic and regulatory scope

Pocket Genes availability and legal status may vary by region, provider arrangement, integration type, and product function. Region-specific review applies before materially expanding into diagnosis, treatment recommendation, variant interpretation, risk scoring, or clinical decision support.

Pocket Genes responsibilities

  • Keep intended-use statements aligned with actual product functionality.
  • Separate access, education, community, and provider report responsibilities.
  • Review intended use before materially expanding clinical or scientific functionality.
  • Avoid presenting education, matching, or community content as clinical advice.

User, provider, and organization responsibilities

  • Users should seek qualified professional advice for clinical decisions.
  • Providers remain responsible for reports and report-specific clinical interpretation.
  • Organizations should label content accurately and avoid claims outside their authority or evidence.

Additional scope notes

  • A provider-specific integration may have additional intended-use statements.
  • A future feature may require separate regulatory analysis.
  • Local law may impose additional restrictions or obligations.

How to make a request or report a problem

Privacy, account, deletion, accessibility, safety, trusted-organization, and security requests can be sent to support@goldencrowvs.com. Use a subject line that identifies the issue, the affected Pocket Genes account or workflow, and whether the request is urgent.

Pocket Genes may need to verify the requester before changing or disclosing account information. Verification is handled proportionally to the request, the sensitivity of the information, and the risk of giving account access or private information to the wrong person.

Effective date, version, and review history

ItemValue
Effective dateAugust 14, 2026
Version1.1
Last reviewedAugust 2026
Material changesExpanded Trust Center format, operator identity, data-map boundaries, request paths, and responsibility sections.
Previous versionJuly 2026 Trust Center overview copy.

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