Informed consent
Missing consent creates serious risk in a negligence claim.
Equipment
Missing informed consent creates serious risk in a negligence claim.
The most important and highest-risk documents for healthcare.
Insurer agreement2027-09Current
Device registrationexpires in 10 daysExpiring soon
Professional licensepermanentCurrent
Where the risk lies
Facility health license
Required for hospital, clinic or laboratory operations.
Facility
Staff professional licenses
Evidence that staff are legally authorized to practice.
Owner
Privacy notice (sensitive personal data)
Health information is sensitive personal data, requiring express written consent.
Owner
12 critical documents, grouped by the risk they address
Alongside the corporate foundation every company needs in order: incorporation deed and bylaws, corporate books and notarial powers of attorney.
Health Licenses and Authorizations
- Facility Health LicenseFor a hospital, clinic, laboratory or medical supply warehouse.
- Health Officer NoticeThe official document naming the person legally responsible for operations.
- Operating NoticesFor healthcare services requiring official notification rather than a license.
Clinical Records and Data Protection
- Informed Consent FormsDocuments recording a patient’s agreement to procedures. Missing consent creates serious risk in a negligence claim.
- Privacy Notice (Sensitive Personal Data)Health status is sensitive personal data. The law requires express written consent for its processing, overseen by the Ministry of Anti-Corruption and Good Governance (formerly INAI).
- Patient Records (Digitized)Clinical histories must remain traceable and secure. NOM-004-SSA3-2012 requires retention for at least five years after the last medical act.
Device and Medicine Management
- Medical Device Health RegistrationsEach device supplied by the company, except exempt low-risk devices, needs a current registration: five years initially, with ten-year renewals.
- Good Storage and Distribution Practice CertificatesEvidence that supplies were not damaged in transit.
- Medical Equipment Maintenance AgreementsWarranties and maintenance logs showing that equipment, such as scanners and monitors, works correctly.
Relationships with Professionals and Hospitals
- Medical Services AgreementsAgreements with physicians, nurses and specialists.
- Staff Qualifications and Professional LicensesA pharmaceutical company or clinic must retain evidence that its staff are legally authorized to practice.
- Agreements with Insurers and Public HospitalsOutsourced service agreements with strict compliance clauses.
Which documents must a healthcare institution retain, starting with clinical records?
Each patient’s clinical record, retained for at least five years after the last medical act under NOM-004-SSA3-2012, with informed consent; the facility’s health license; staff professional licenses; and the privacy notice, because health information is sensitive personal data.
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Healthcare
12 critical documents
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