Regulation & Compliance

Explanation and remarks on Dental Imaging regulation

 

 

Note: This article is based only on Italian legislation. For other countries check the local regulations.

 

 

 

 

The retention of records is a task that concerns all health fields, and both public and private health sectors are not excluded. Healthcare companies, therefore, must comply with the (often rigorous) regulations that guarantee patients’ safety.

For how long and how exactly should medical records be kept? What is the relevant legislation? And how should these records be kept? This article answers these questions, and may help you comply accordingly.

We will cover the following topics:

  • Legislation
  • Handbook
  • Retention periods of health records
  • Retention periods of health data
  • Storage

LEGISLATION

The main regulatory references regarding the conservation of medical records are essentially these three:

  1. The circular of the Ministry of Health dated 19 December 1986 n. 900, in which a reference is made to the conservation of medical records and related reports;
  2. Article 5 of the ministerial decree of 18 February 1982;
  3. Article 4 of the ministerial decree of February 14, 1997. Which is more specific for radiological documentation;

THE HANDBOOK

This book of guidelines identifies numerous document types common in public health organizations and describes their relative storage periods, indicating the documents to be kept and for how long, as required by national legislation and technical opinions.

The handbook guides public health companies how to properly manage the archive discarding process, so that only necessary documentation is kept.

RETENTION PERIODS OF HEALTH RECORDS

The handbook contains lists that refer to records stored on any media format, analog (paper, plate, microfilm) and digital (original copy  or processed replicas).

  • Health records that should be kept indefinitely

The main ones are: Health checks on employees, medical records of public and private hospitals, registers, documents of processing of personal data consents, laboratory tests, competitions, reports (autopsy, cytological, histological, laboratory, nuclear medicine, emergency room), radiographs.

  • Health records that should be kept until cessation of activity

Records about Food, clinics, nursing homes and analysis laboratories; complaints regarding beehives;  guarantee certificates for machinery and equipment, health facilities deposits.

  • Health records that should be kept for 40 years

Compensation for employees absent from work due to illness/accident.

  • Health records that should be kept for 30 years

Production activities, liquidation, decrees and ordinances.

  • Health records that should be kept for 20 years

Activities of the local medical commission regarding certain licenses, blood tests (blood group determination records, irregular antibodies, transfusion reactions, compatibility tests).

  • Health records that should be  kept for 10 years

The main ones are: Invoices, direct and indirect assistance, account statements, cash flow statements, consultancy, x-rays.

 

RETENTION PERIODS OF HEALTH DATA 

Before approaching this topic, we must clarify: the conservation of health records and health data, even if they may seem alike, are not similar. In fact, the GDPR established the difference between these two.

The question of how the processing of personal data has changed with the GDPR is complex. From a data management within healthcare organization point-of-view, two things must be kept in mind:

  • Storage periods of health records, as outlined in The Handbook, are indisputable. Therefore, even the personal data contained inside will be kept for the period indicated.
  • In all other cases, the provisions of article 5, part 1, letter e of the aforementioned GDPR apply. That is, those who request permission to process personal data must also specify the period of time they need this data, and undertake to permanently delete them at the expiry of this term.

 

Conservation of Documents

There are two distinguished cases when dealing with conservation, each with a different solution:

  • Digital / digitized documents

If documents are originally digital or are the result of a process of digitizing original copies of paper, then public administrations must use digital preservation. This is actually the only possible way to guarantee the authenticity and availability of digital documents.

  • Paper documents

For paper documents, archiving requires specific spaces to allocate documents. These are physical spaces that must be managed in a certain way, and must ensure all the necessary security measures, not only for the stored documents, but also for the people who work there.

How do we keep medical records at DentQ?

The DentQ Archiving System uses a Digital Data retention model. The collection of personal information takes place in complete safety and guarantees the rapid availability online, in our secured cloud,  of the exams, the archived documentation and the related interactive AI services and planning tools.

Dentists and patients that use our digitized Dental Imaging service appreciate our fast and reliable system, not only for its technical quality, but also for the effective organization of the workflow,  in compliance with current rigorous regulations.

 

Source: Bucap.it – How long and in what way should clinical records be kept.

Elaborated by Dr. Enrico Cammarella – Lead Radiographer DentQ Italy