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Recommendations for responsible monitoring and regulation of clinical software systems. American Medical Informatics Association, Computer-based Patient Record Institute, Medical Library Association, Association of Academic Health Science Libraries, American Health Information Management Association, American Nurses Association.

In mid-1996, the FDA called for discussions on regulation of clinical software programs as medical devices. In response, a consortium of organizations dedicated to improving health care through information technology has developed recommendations for the responsible regulation and monitoring of clinical software systems by users, vendors, and regulatory agencies. Organizations assisting in development of recommendations, or endorsing the consortium position include the American Medical Informatics Association, the Computer-based Patient Record Institute, the Medical Library Association, the Association of Academic Health Sciences Libraries, the American Health Information Management Association, the American Nurses Association, the Center for Healthcare Information Management, and the American College of Physicians. The consortium proposes four categories of clinical system risks and four classes of measured monitoring and regulatory actions that can be applied strategically based on the level of risk in a given setting. The consortium recommends local oversight of clinical software systems, and adoption by healthcare information system developers of a code of good business practices. Budgetary and other constraints limit the type and number of systems that the FDA can regulate effectively. FDA regulation should exempt most clinical software systems and focus on those systems posing highest clinical risk, with limited opportunities for competent human intervention.

Clinical Medicine↗

Position statement. Restructuring, work redesign, and the job and career security of registered nurses. American Nurses Association.

The American Nurses Association (ANA) is committed to safeguarding the public, protecting and advancing the careers of professional nurses, supporting individual and collective efforts by registered nurses to protect their clients and enhancing the professional development and job security of registered nurses. As the nation's health care system is restructured, ANA is actively engaged in initiatives to strengthen the economic and general welfare of registered nurses, the safety and care for the public, and, in partnership with the state nurses associations (SNAs), oppose efforts to replace registered nurses with inappropriate substitutes.

American Nurses' Association↗

American Nurses Association Position Statement on guidelines for commercial support of continuing nursing education.

The attached guidelines on "Commercial Support of Continuing Nursing Education" have been developed by the American Nurses Association (ANA) to assist/guide nursing continuing educators who wish to utilize the resources of corporations to provide continuing education programs. These guidelines enable the provider to maintain a balance between the need for industry-supported dissemination of scientific information and promotional activities which meet the requirements of law, as well as professional standards of the American Nurses Association.

American Nurses' Association↗

Position statement. The right to accept or reject an assignment. American Nurses Association.

The American Nurses Association (ANA) believes that nurses should reject assignment that puts patients or themselves in serious, immediate jeopardy. ANA supports the nurses obligation to reject an assignment in these situations even where there is not a specific legal protection for rejecting such an assignment. The professional obligations to the nurse to safeguard clients are grounded in the ethical norms of the profession, the Standards of Clinical Nursing Practice and state nurse practice acts.

American Nurses' Association↗