Legal

Professional Disclaimer

Important information about the nature and limitations of HistoCraft. Please read this page carefully before using the service.

Last updated: April 2026

Not a Medical Device

HistoCraft is not classified as a medical device under EU Regulation 2017/745 (MDR). It does not diagnose, treat, monitor, predict, or prevent any disease or condition.

Not a Diagnostic Tool

HistoCraft does not analyze, interpret, or evaluate medical data. It does not provide clinical decision support, diagnostic suggestions, or treatment recommendations of any kind.

No Patient Data Storage

No patient data, health records, or diagnostic information is stored on our servers. All patient-related data is processed exclusively in your browser and discarded when you leave.

Professional Responsibility

All medical content, diagnoses, and clinical decisions are the sole responsibility of the licensed professional. HistoCraft is a formatting tool that structures the professional's own input.

Nature of the Service

  • HistoCraft is a browser-based report formatting and structuring tool designed for licensed anatomopathologists. Its sole purpose is to help qualified medical professionals format histopathological reports more efficiently using customizable templates.
  • HistoCraft is a productivity tool, comparable to a word processor with specialized templates. It does not perform any medical function. The software does not: analyze tissue samples or medical images; suggest, recommend, or validate diagnoses; interpret laboratory results or clinical data; provide a second opinion or quality assurance on diagnostic work; make clinical decisions or influence medical judgment in any way.
  • The European Union Medical Device Coordination Group guidance (MDCG 2019-11) explicitly excludes software intended for "storage, format conversion, and display" from the definition of medical device software. HistoCraft falls squarely within this exclusion.

Template Content Disclaimer

  • Templates provided by HistoCraft are generic scientific frameworks based on published literature and international reporting guidelines (such as ICCR, CAP, and WHO classification systems). These templates are provided for formatting convenience only.
  • Templates DO NOT constitute medical advice, clinical guidelines, standard-of-care recommendations, or endorsed diagnostic criteria. They are reference frameworks that the professional must independently evaluate, adapt, and verify.
  • Templates may not reflect the most current scientific literature, updated classification systems, or the specific reporting requirements of your institution or jurisdiction. It is the professional's sole responsibility to ensure that all report content is accurate, complete, current, and appropriate for the specific clinical context.
  • HistoCraft makes no representation or warranty that any template is suitable for any particular diagnostic scenario, patient population, or clinical purpose.

Professional Use Only

  • HistoCraft is intended exclusively for use by licensed healthcare professionals who are qualified, trained, and authorized to produce histopathological reports in their jurisdiction.
  • By using HistoCraft, you represent and warrant that you hold the necessary professional qualifications, licenses, and institutional authorizations to produce histopathological reports.
  • Reports generated using HistoCraft must be reviewed, verified, and approved by the responsible pathologist before being used for any clinical, diagnostic, therapeutic, or patient care purpose.
  • HistoCraft must not be used as a substitute for professional medical judgment, training, or experience. The software does not replace or diminish the professional's duty of care to their patients.

Limitation of Liability

  • TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, HistoCraft, its officers, directors, employees, agents, and affiliates shall not be liable for:
  • Any clinical decisions, diagnoses, or medical outcomes arising from the use of reports generated with the service.
  • Any errors, omissions, or inaccuracies in generated reports, whether caused by template content, user input, software behavior, or any other factor.
  • Any patient harm, misdiagnosis, delayed diagnosis, incorrect treatment, or adverse clinical outcome that may be associated with the use of HistoCraft-generated reports.
  • Any loss of data resulting from the browser-based architecture of the service. Users are responsible for exporting and saving their reports through their own systems.
  • Any indirect, incidental, special, consequential, or punitive damages, including but not limited to loss of profits, revenue, business opportunities, or professional reputation.
  • The licensed professional who uses HistoCraft assumes full and exclusive responsibility for all reports they produce, regardless of whether templates, auto-generated text, or other software features were used in the creation of those reports.

No Telemedicine or Diagnostic Platform

  • HistoCraft is NOT a telemedicine platform, a diagnostic platform, a laboratory information system (LIS), a hospital information system (HIS), an electronic health record (EHR) system, or a pathology information management system.
  • HistoCraft does not facilitate communication between healthcare providers and patients. It does not transmit diagnostic results to patients or other healthcare providers.
  • HistoCraft does not integrate with clinical workflows, laboratory instruments, or hospital systems. It is a standalone report formatting tool.

Regulatory Status

  • HistoCraft is not registered, certified, or approved as a medical device by any regulatory authority, including but not limited to the European Medicines Agency (EMA), the Romanian National Agency for Medicines and Medical Devices (ANMDMR), the U.S. Food and Drug Administration (FDA), or any other national or international regulatory body.
  • This is because HistoCraft does not meet the definition of a medical device under EU Regulation 2017/745 (MDR), as it does not have a medical purpose and does not perform actions beyond storage, formatting, and display of information as entered by the user.
  • HistoCraft is not subject to the EU In Vitro Diagnostic Regulation (IVDR 2017/746) as it does not analyze biological samples or provide diagnostic results.

Applicable Law

  • This disclaimer is governed by the laws of Romania and, where applicable, the mandatory provisions of European Union law.
  • Nothing in this disclaimer limits or excludes liability that cannot be limited or excluded under applicable law, including EU consumer protection legislation.
  • If any provision of this disclaimer is found to be unenforceable, the remaining provisions continue in full force and effect.

Contact

  • For questions about this disclaimer or the legal status of HistoCraft, contact us at legal@histocraft.com.

Questions about this disclaimer?