This chapter critically analyzes the legal and regulatory framework for Electronic Health Records in Europe and the US. At both parts of the world, the development of EHRs is evolving quickly, but many different approaches have proven possible. Different approaches resulted in different EHR solutions and different regulatory instruments. In Europe governmental bodies have been the driving force behind the development and implementation of EHRs. Consequently many European countries established a new legal framework simultaneously with the roll-out of government-initiated eHealth structures. In the US the driving force was – up until now – not so much the government, but rather private companies, insurance companies and healthcare organizations. Not surprisingly, this resulted in a strong focus on Personal Health Records. Last year however, the US government issued the largest stimulus package ever in order to encourage the adoption of EHR solutions. From this insight the question arises whether the legal regulation of electronic patient records is a prerequisite to their roll-out and acceptance or is it really just an unavoidable by-product?
Dumortier J, Verhenneman G. Legal Regulations on Electronic Health Records: A Prerequisite or an Unavoidable By-Product? - The Legal Aspects of Electronic Health Records in Europe and the US Analysed. SSRN [Internet]. 2011 Dec 22;ICRI Research Paper No. 5. Available from: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1975758##