requires resort to doctrines of equitable remedies. A hardware or software vendor's insolvency raises issues under federal bankruptcy law. Finally, interaction of computer-based record systems with artificial intelligence systems can also raise issues concerning medical device laws and, to the extent that nonphysicians are able to diagnose and treat patients without physician involvement using these systems, physician licensure laws.
Because of the plethora of laws that apply to computer-based patient records and record systems, one paper cannot encompass a full discussion of the application of these laws to the computer-based record. What follows, therefore, is a summary discussion of the key legal issues raised by computer-based patient records and record systems: regulatory and accreditation issues, evidentiary issues, patient privacy and record access concerns, record ownership questions, legal risks specific to computer-based patient record systems, and computer contracting issues.
Computer-based patient records utilized by an institutional health care provider must meet the requirements of relevant state licensure laws, or the institution may face licensure sanctions. The statutes and regulations governing licensure of hospitals, nursing homes, health maintenance organizations, ambulatory surgical treatment centers, and other institutional providers generally contain specific standards and requirements concerning the creation, authentication, retention, and storage of patient records, as well as limitations on the media permissible for their creation and storage. Additional requirements typically found in state licensure statutes and regulations relate to confidentiality, record content, accuracy, completeness, timeliness, and accessibility.
State hospital licensure laws still pose barriers to full automation of the patient record. State-to-state variances in medical records requirements and obsolete and ambiguous or conflicting laws and regulations pose obstacles to the full development of computer-based patient record systems.1 Although some state regulators may permit computerization of patient records in ways that technically are not permitted by state regulations, a health care institution