In response to the digitalization trend of healthcare information, the Medical Care Act was amended in 2004 to include the following provision under a newly added Article 69: "Healthcare institutions which prepare and retain medical records via electronic means shall be exempt from producing a hard copy thereof. The regulations regarding the criteria, production method, content, and other requirements for electronic medical records shall be set forth by the central competent authority.
The regulations regarding the criteria, production method, content, and other requirements for electronic medical records shall be set forth by the central competent authority". Pursuant to such provision, the central competent authority at the time, the Department of Health (later restructured and became the Ministry and Health and Welfare), promulgated the Regulations Governing the Preparation and Management of Electronic Medical Records by Healthcare Institutions (these "Regulations") in 2005, which have been in force since then with certain amendments made in 2008 and 2009.
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