Register of congenital malformations

Description of file,
as of 2 March 2006
(In accordance with section 10 of the Personal Data Act 523/1999)

1. CONTROLLER

Name: National Research and Development Centre for Welfare and Health (STAKES)
Postal address: PO Box 220
Postcode: FI-00531 Helsinki
Street address: Lintulahdenkuja 4, 00530 Helsinki, Finland
Tel.: +358 20 610 6000
Fax: +358 20 610 7324

2. PERSON RESPONSIBLE FOR THE REGISTER

Name: Annukka Ritvanen
Position: Senior Researcher
Postal address: STAKES / STAKES Information / Register of Congenital Malformations
PO Box 220, 00531 Helsinki, Finland
Tel.: +358 20 610 7376
Fax: +358 20 610 7324
E-mail: annukka.ritvanen[at]thl.fi

3. NAME OF THE REGISTER

Register of Congenital Malformations

4. GROUNDS FOR MAINTAINING THE REGISTER

Statutory
* Act on National Personal Data Registers Kept under the Health Care System (556/1989), Section 2
* Decree on National Personal Data Registers Kept under the Health Care System (774/1989), Sections 1 and 8
* Act on the National Research and Development Centre for Welfare and Health (1073/1992), Section 2

5. PURPOSE OF THE REGISTER

Statistics and research. Surveillance of congenital anomalies.

6. DATA SUBJECTS

The Register of Congenital Malformations contains national-level data on congenital chromosomal and structural anomalies detected in stillborn and live born infants and foetuses. Data on some 4000 congenital anomalies are annually reported to the Register, of which some 2000 are major congenital anomalies.

The Register of Congenital Malformation was established on 29 December 1962. Registration of anomaly data began on 1 January 1963.

7. TYPES OF DATA IN THE REGISTER

1. Mother

- name
- personal identity code
- municipality of residence
- nationality (Finnish or other)
- previous pregnancies (number)
- previous deliveries (number)
- previous stillbirths (number)
- previous spontaneous abortions (number)
- previous abortions induced for foetal indications (number)

2. Data on present pregnancy

- mother's work / employment
- mother's diseases and pregnancy-related complications, week of gestation
- mother's medication and vaccinations, week of gestation
- other exposures, week of gestation
- foetal screenings and examinations during pregnancy, week of gestation and the original reason for foetal examinations (screening, an irregular course of the pregnancy, etc.)
- number of foetuses

3. Infant/foetus

- name
- personal identity code or date of birth
- duration of pregnancy
- delivery/abortion hospital
- type of birth (live birth or stillbirth, induced abortion, miscarriage)
- sex
- letter indicating the order of birth in multiple pregnancy
- weight at birth
- date of death, if applicable

4. Congenital anomalies

- diagnosis in words
- diagnosis with ICD codes
- time of detecting the anomaly (during pregnancy, neonatal period, etc.)
- detection of anomalies during pregnancy (method of examination, week of gestation)
- further testing after birth for anomaly detection
- chromosomal and DNA testing and test results
- X-ray and ultrasound examinations, etc.
- autopsy
- other examinations

5. Anomalies in family members (family members' personal identification not registered)

- type of family relationship (mother, father, brother, sister, etc.)
- diagnosis in words
- diagnosis with ICD codes

6. Data on the notification of anomaly

- type of notification (form, other notification etc.)
- notifying unit
- date of receiving and date of processing the notification

8. REGULAR DATA SOURCES OF THE REGISTER

a) Health-care authorities, institutions and professionals (physicians, hospitals, prenatal and child-welfare clinics)

b) Cytogenetic laboratories

c) Medical Birth Register. Care Register for Health Care. Register of Induced Abortions. Register of Visual Impairment

d) Statistics Finland: Cause-of-Death Statistics

Grounds:

a) and b) Act on National Personal Data Registers Kept under the Health Care System (556/1989), Section 3

Decree on National Personal Data Registers Kept under the Health Care System (774/1989), Section 8

c) The registers are used to complete and verify data according to the data content of the Register of Congenital Malformations.

Act on National Personal Data Registers Kept under the Health Care System (556/1989), Section 3

Decree on National Personal Data Registers Kept under the Health Care System (774/1989), Sections 2, 3, 6, 8 and 9

d) Permissions for use TK-53-58-02 (TK-53-984-96, TK-53-932-92, TK-53-87-87), granted by Statistics Finland, Cause-of-Death Statistics

9. REGULAR DISCLOSURE OF REGISTER DATA

Register data are not disclosed regularly.

STAKES is authorised to disclose data in the Register of Congenital Malformations to researchers for scientific research purposes after consulting the Data Protection Ombudsman.

10. RIGHT OF ACCESS TO DATA AND RIGHT TO RECTIFY ERRONEOUS DATA

The data subjects have no right of access to and no right to rectify the data entered into the register, because the Register of Congenital Malformations is a statutory statistical and research register and the personal data stored in it are not used in decision-making or care concerning the data subjects.

11. INFORMATION ON THE PROCESSING OF DATA

The controller is not liable to inform the data subjects of data processing, because the Register of Congenital Malformations is a statutory register.

12. PRINCIPLES CONCERNING PROTECTION OF THE FILES

The data stored in the Register of Congenital Malformations are confidential under section 4 of the Act on National Personal Data Registers Kept under the Health Care System (556/1989).

The Register of Congenital Malformations functions in accordance with the STAKES data security guidelines, which were adopted on 1 December 2004.

The materials of the Register of Congenital Malformations, both in paper and electronic form, are kept in locked premises. Access to the premises is given only to certain named employees responsible for the Register. Electronic material is protected by user names and passwords. The Register uses access control software (auditing log).

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