Legal aspects


The HTA Core Model specifies four categories of legal aspects of importance to HTA (1):

In addition, when assessing diagnostic technologies, legal issues related to who is the end-user are also of importance (1).

Sources to search

Legal aspects related to health care policy refer to international or supranational rules and regulations (such as European law) and in particular to national law. Droste and Rixen (2) recommend the use of the following information sources for legal issues directly related to the health technology in question:

-Health policy administration, Decision-making bodies, Health insurances etc. (Benefit rights)
-European Medicines Agency (EMA), National agencies etc. (Pharmaceutical legislation)
-Notified Bodies (European Union), National authorities etc. (Medical device law)
-Governments, Parliaments, Authorities with legislative rights etc. (Rehabilitation and care legislation, Hospital law, Remuneration law)
-Medical Council etc. (Professional law)
-Government, Parliament, Legislative Authorities (Criminal law)
-Government, Parliament, Federal / National Court of Justice, Higher District Court etc. (Liability law)
-World Health Organization (WHO), EU Council of Ministers, Government, Parliament, Federal / National Social Court, Federal / National Constitutional Court etc. (Patient rights)

Sources for patents may be consulted when looking for information on whether the technology in question infringes some intellectual property rights or whether the introduction of the technology means there will be additional licensing fees to be paid (1).

Depending on the topic in question, the following information sources (searchable in English language) may be used when searching for legal issues directly related to the patient and e.g. his/her basic rights and freedoms (2):

Further, hand-searching for non-indexed journals and searching of the web pages of relevant health law and ethics institutes may be considered (2).

Designing search strategies

No internationally established standard exists for how to develop search strategies on legal aspects related to health technologies (2). A study by Droste and Rixen (2) introduces a proposal for an information retrieval procedure similar to the workflow of information retrieval for effectiveness assessments.

One should first try to identify relevant laws, rules and regulations, and legal issues relevant to the topic of interest (2). When defining the research question, it is recommended to add an additional category related to the legal aspects to the PICO scheme describing the population, intervention, comparator, and outcomes of interest (PICOL). In databases that allow advanced searching, subject headings and text words describing the relevant legal issues are then combined with search terms characterising the selected relevant PICO categories, with the Boolean operator AND. The paper of Droste and Rixen (2) provides an overview of relevant subject headings for searching for legal aspects in MEDLINE and Embase. Use of less sophisticated search strategies may need to be considered in other types of sources.

Patent information cannot be searched using standardized search approaches and it is considered to be challenging (4). A human recombinant insulin case study by Dirnberger (4) compared the performance of three different search approaches: "crude” keyword search strategy, complex focused keyword search strategy, and sequence search strategy. The best search results in terms of recall and precision were achieved by combining the focused keyword and sequence search approaches.

There is some overlap between ethical, legal and social aspects of health technologies (2). For example, issues of patient autonomy are part of each of these aspects. To avoid duplication of work, joint information retrieval processes for these three aspects may therefore be considered. 


Reference list