The Icelandic Healthcare Database:

Kari Stefansson, MD, Dr.Med., deCODE genetics, Inc., Reykjavik, Iceland

Disclosures

July 13, 2001

In This Article

Ethical Considerations of the Icelandic Healthcare Database

The construction of the anonymous Icelandic Healthcare Database involves many ethical issues that will become important for similar databases developed elsewhere. Important to note is that the issues discussed in this section are less hampered by the consequences genetic information may have on medical insurance status, given that Iceland has a single-payer healthcare system. This database will conform to the recommendations of the HUGO (The Human Genome Organisation) Ethics Committee, as well as or better than any preceding genetics study.

Community Consent

First, there is the issue of informed consent. The Icelandic Parliament and the Health Ministry -- which oversee the healthcare system in Iceland -- have agreed to allow irreversibly encrypted medical data to be transferred to the database without explicit informed consent by individuals in Iceland. This "permission" is in the form of a government bill, introduced by the Minister of Health at the initiative of deCODE genetics, which entitles the Icelandic Ministry of Health the right to grant a license to a company to build a database containing medical records of all Icelanders that could be linked to genetic and genealogical information. However, Icelanders will be able to opt out of the database at any time as well as during the period of more than 6 months following passage of this bill, but before any data are actually transferred. This protocol for the handling of medical data is in keeping with Icelandic law on patient rights and medical ethics as well as international standards on the use of medical epidemiological data by hospitals, researchers, and governments, all of whom carry out epidemiological studies using medical data without active informed consent by patients.

Individual Consent

We will obtain informed consent for generating genetic data and for linking it to the medical information in the database, at the time of blood collection from Icelandic volunteers.

Privacy

As described above, the database will be irreversibly encrypted by independent groups, and direct access to its content will be very restricted. Only information involving groups of at least 10 individuals will be revealed during database queries in order to prevent someone from illegally attempting to identify any one individual using a set of known characteristics. In fact, if one wished to obtain medical information about someone in Iceland, it would be orders of magnitude easier to obtain that information from the hospital computer systems where original data lie unencrypted (which is true not just in Iceland but in most hospitals worldwide).

Freedom of Science

deCODE genetics will have exclusive rights to market the database for 12 years outside Iceland but not the exclusive right to use it. The Health Ministry will have free access, as will academic researchers who agree not to hand over data to commercial clients. The database will not prevent independent Icelandic scientists from continued access to patients, their doctors, or original medical data in hospitals. In exchange for access to these medical data, deCODE genetics must, in turn, upgrade the entire informatics systems of the Icelandic healthcare organization -- this will benefit all researchers and physicians in Iceland.

Benefits to Iceland

Icelanders will gain in the form of hundreds of new high-technology jobs which will further decrease the so-called "brain drain" that plagues Iceland and other small countries. The company is currently majority-owned by Icelanders (70%), so most of the value that deCODE genetics accrues will further benefit Iceland. Additionally, there will be the opportunity to improve the efficiency and effectiveness of healthcare if the Icelandic healthcare system can apply what is learned.

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