메뉴 건너뛰기




Volumn 4, Issue 6, 1997, Pages 442-457

Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL MEDICINE; COMPUTER PROGRAM; COMPUTER SYSTEM; FOOD AND DRUG ADMINISTRATION; HUMAN; INFORMATION SYSTEM; SAFETY; STANDARD; UNITED STATES;

EID: 0031279425     PISSN: 10675027     EISSN: None     Source Type: Journal    
DOI: 10.1136/jamia.1997.0040442     Document Type: Article
Times cited : (63)

References (63)
  • 1
    • 0347795546 scopus 로고    scopus 로고
    • July 15
    • Federal Register. July 15, 1996. 61:36886-7.
    • (1996) Federal Register , vol.61 , pp. 36886-36887
  • 3
    • 0347795545 scopus 로고
    • AMIA News
    • AMIA News. J Am Med Inform Assoc. 1994;1:91-2.
    • (1994) J Am Med Inform Assoc. , vol.1 , pp. 91-92
  • 7
    • 0026892091 scopus 로고
    • The Regenstrief Medical Record System: 20 years of experience in hospitals, clinics, and neighborhood health centers
    • McDonald CJ, Tierney WM, Overhage JM, Martin DK, Wilson GA. The Regenstrief Medical Record System: 20 years of experience in hospitals, clinics, and neighborhood health centers. MD Comput. 1992;9:206-17.
    • (1992) MD Comput. , vol.9 , pp. 206-217
    • McDonald, C.J.1    Tierney, W.M.2    Overhage, J.M.3    Martin, D.K.4    Wilson, G.A.5
  • 8
    • 0021186343 scopus 로고
    • The application of computer-based medical record systems in ambulatory care
    • Barnett GO. The application of computer-based medical record systems in ambulatory care. N Engl J Med. 1984;310: 1643-50.
    • (1984) N Engl J Med. , vol.310 , pp. 1643-1650
    • Barnett, G.O.1
  • 9
    • 0023785432 scopus 로고
    • Computer-stored medical records: Their future role in medical practice
    • McDonald CJ, Tierney WM. Computer-stored medical records: their future role in medical practice. JAMA. 1988; 259:3433-40.
    • (1988) JAMA , vol.259 , pp. 3433-3440
    • McDonald, C.J.1    Tierney, W.M.2
  • 10
    • 0022616424 scopus 로고
    • The effects of computerized medical records on provider efficiency and quality of care
    • Garrett LE Jr, Hammond WE, Stead WW. The effects of computerized medical records on provider efficiency and quality of care. Meth Inform Med. 1986;25:151-7.
    • (1986) Meth Inform Med. , vol.25 , pp. 151-157
    • Garrett L.E., Jr.1    Hammond, W.E.2    Stead, W.W.3
  • 12
    • 0000324478 scopus 로고
    • The Medical Archival System: An Information Retrieval System based on Distributed Parallel Processing
    • Yount RJ, Vries JK, Councill CD. The Medical Archival System: an Information Retrieval System based on Distributed Parallel Processing. Information Processing & Management. 1991;27:379-89.
    • (1991) Information Processing & Management , vol.27 , pp. 379-389
    • Yount, R.J.1    Vries, J.K.2    Councill, C.D.3
  • 13
    • 0347165535 scopus 로고
    • Total integration of health center information through distributed parallel processing
    • Vries JK, Yount RJ, Singh J: Total integration of health center information through distributed parallel processing. HIMSS Proceedings. 1994;4:241-52.
    • (1994) HIMSS Proceedings , vol.4 , pp. 241-252
    • Vries, J.K.1    Yount, R.J.2    Singh, J.3
  • 16
    • 0014572826 scopus 로고
    • Computer evaluation of acid-base disorders
    • Bleich HL. Computer evaluation of acid-base disorders. J Clin Invest. 1969;48:1689-96.
    • (1969) J Clin Invest. , vol.48 , pp. 1689-1696
    • Bleich, H.L.1
  • 17
    • 0015320817 scopus 로고
    • Computer-aided diagnosis: Description of an adaptable system, and operational experience with 2,034 cases
    • Horrocks JC, McCann AP, Staniland JR, Leaper DJ, de Dombal FT: Computer-aided diagnosis: description of an adaptable system, and operational experience with 2,034 cases. Br Med J. 1972;2:5-9.
    • (1972) Br Med J. , vol.2 , pp. 5-9
    • Horrocks, J.C.1    McCann, A.P.2    Staniland, J.R.3    Leaper, D.J.4    De Dombal, F.T.5
  • 18
    • 0017195791 scopus 로고
    • Toward the simulation of clinical cognition: Taking a present illness by computer
    • Pauker SG, Gorry GA, Kassirer JP, Schwartz WB: Toward the simulation of clinical cognition: taking a present illness by computer. Am J Med. 1976;60:981-96.
    • (1976) Am J Med. , vol.60 , pp. 981-996
    • Pauker, S.G.1    Gorry, G.A.2    Kassirer, J.P.3    Schwartz, W.B.4
  • 20
    • 84943986834 scopus 로고
    • Antimicrobial selection by computer: A blinded evaluation by infectious disease experts
    • Yu VL, Fagan LM, Wraith SM, et al: Antimicrobial selection by computer: a blinded evaluation by infectious disease experts. JAMA. 1979;242:1279-82.
    • (1979) JAMA , vol.242 , pp. 1279-1282
    • Yu, V.L.1    Fagan, L.M.2    Wraith, S.M.3
  • 21
    • 0019331893 scopus 로고
    • Judgement and computers
    • Blois MS. Judgement and computers. N Engl J Med. 1980; 303:192-7.
    • (1980) N Engl J Med. , vol.303 , pp. 192-197
    • Blois, M.S.1
  • 22
    • 0020001973 scopus 로고
    • Internist-1: An experimental computer-based diagnostic consultant for general internal medicine
    • Miller RA, Pople HE Jr, Myers JD: Internist-1: an experimental computer-based diagnostic consultant for general internal medicine. N Engl J Med. 1982;307:468-76.
    • (1982) N Engl J Med. , vol.307 , pp. 468-476
    • Miller, R.A.1    Pople H.E., Jr.2    Myers, J.D.3
  • 23
    • 85047694791 scopus 로고
    • DXplain: An evolving diagnostic decision-support system
    • Barnett GO, Cimino JJ, Hupp JA, Hoffer EP: DXplain: an evolving diagnostic decision-support system. JAMA. 1987; 258:67-74.
    • (1987) JAMA , vol.258 , pp. 67-74
    • Barnett, G.O.1    Cimino, J.J.2    Hupp, J.A.3    Hoffer, E.P.4
  • 24
    • 0024111053 scopus 로고
    • ILIAD as an expert consultant to teach differential diagnosis
    • New York: IEEE Computer Society Press
    • Warner HR, Haug P, Bouhaddou O, et al. ILIAD as an expert consultant to teach differential diagnosis. Proc Twelfth Ann Symp Comput Appl Med Care. New York: IEEE Computer Society Press, 1987;371-6.
    • (1987) Proc Twelfth Ann Symp Comput Appl Med Care , vol.6-371
    • Warner, H.R.1    Haug, P.2    Bouhaddou, O.3
  • 25
    • 0024550252 scopus 로고
    • A computer-assisted medical diagnostic consultation service. Implementation and prospective evaluation of a prototype
    • Bankowitz RA, McNeil MA, Challinor SM, Parker RC, Kapoor WN, Miller RA: A computer-assisted medical diagnostic consultation service. Implementation and prospective evaluation of a prototype. Ann Intern Med. 1989;110:824-32.
    • (1989) Ann Intern Med. , vol.110 , pp. 824-832
    • Bankowitz, R.A.1    McNeil, M.A.2    Challinor, S.M.3    Parker, R.C.4    Kapoor, W.N.5    Miller, R.A.6
  • 26
    • 0028367412 scopus 로고
    • Medical diagnostic decision support systems -past, present, and future
    • Miller RA. Medical diagnostic decision support systems -past, present, and future. J Am Med Inform Assoc., 1994;1: 8-27.
    • (1994) J Am Med Inform Assoc. , vol.1 , pp. 8-27
    • Miller, R.A.1
  • 27
    • 0017181612 scopus 로고
    • Protocol-based computer reminders, the quality of care and the non-perfectability of man
    • McDonald CJ. Protocol-based computer reminders, the quality of care and the non-perfectability of man. N Engl J Medicine. 1976;295:1351-5.
    • (1976) N Engl J Medicine , vol.295 , pp. 1351-1355
    • McDonald, C.J.1
  • 28
    • 0018903896 scopus 로고
    • Physician response to computer reminders
    • McDonald CJ, Wilson GA, McCabe GP Jr. Physician response to computer reminders. JAMA. 1980;244:1579-81.
    • (1980) JAMA , vol.244 , pp. 1579-1581
    • McDonald, C.J.1    Wilson, G.A.2    McCabe G.P., Jr.3
  • 29
    • 0022761128 scopus 로고
    • Delayed feedback of physician performance versus immediate reminders to perform preventive care: Effects on physician compliance
    • Tierney WM, Hui SL, McDonald CJ. Delayed feedback of physician performance versus immediate reminders to perform preventive care: effects on physician compliance. Medical Care. 1986;24:659-66.
    • (1986) Medical Care , vol.24 , pp. 659-666
    • Tierney, W.M.1    Hui, S.L.2    McDonald, C.J.3
  • 30
    • 0023191993 scopus 로고
    • Computerized display of past test results: Effect on outpatient testing
    • Tierney WM, McDonald CJ, Martin DK, Rogers MP. Computerized display of past test results: effect on outpatient testing. Ann Intern Med. 1987;107:569-74.
    • (1987) Ann Intern Med. , vol.107 , pp. 569-574
    • Tierney, W.M.1    McDonald, C.J.2    Martin, D.K.3    Rogers, M.P.4
  • 31
    • 0023858518 scopus 로고
    • Computer predictions of abnormal test results: Effects on outpatient testing
    • Tierney WM, McDonald CJ, Hui SL, Martin DK. Computer predictions of abnormal test results: effects on outpatient testing. JAMA. 1988;259:1194-8.
    • (1988) JAMA , vol.259 , pp. 1194-1198
    • Tierney, W.M.1    McDonald, C.J.2    Hui, S.L.3    Martin, D.K.4
  • 32
    • 0024543716 scopus 로고
    • Computers
    • McDonald CJ. Computers. JAMA. 1989;261:2834-6.
    • (1989) JAMA , vol.261 , pp. 2834-2836
    • McDonald, C.J.1
  • 33
    • 0025328721 scopus 로고
    • The effect on test ordering of informing physicians of the charges for outpatient diagnostic tests
    • Tierney WM, Miller ME, McDonald CJ. The effect on test ordering of informing physicians of the charges for outpatient diagnostic tests. N Engl J Med. 1990;322:1499-504.
    • (1990) N Engl J Med. , vol.322 , pp. 1499-1504
    • Tierney, W.M.1    Miller, M.E.2    McDonald, C.J.3
  • 34
    • 0028281896 scopus 로고
    • Guidelines you can follow and can trust: An ideal and an example
    • McDonald CJ, Overhage JM. Guidelines you can follow and can trust: an ideal and an example. JAMA. 1994;271:872-3.
    • (1994) JAMA , vol.271 , pp. 872-873
    • McDonald, C.J.1    Overhage, J.M.2
  • 35
    • 84944371864 scopus 로고
    • Computer surveillance of hospital-acquired infections and antibiotic use
    • Evans RS, Larsen RA, Burke JP, et al. Computer surveillance of hospital-acquired infections and antibiotic use. JAMA. 1986;256:1007-11.
    • (1986) JAMA , vol.256 , pp. 1007-1011
    • Evans, R.S.1    Larsen, R.A.2    Burke, J.P.3
  • 36
    • 0025176494 scopus 로고
    • Therapeutic antibiotic monitoring: Surveillance using a computerized expert system
    • Pestotnik SL, Evans RS, Burke JP, Gardner RM, Classen DC. Therapeutic antibiotic monitoring: surveillance using a computerized expert system. Am J Med. 1990;88:43-8.
    • (1990) Am J Med. , vol.88 , pp. 43-48
    • Pestotnik, S.L.1    Evans, R.S.2    Burke, J.P.3    Gardner, R.M.4    Classen, D.C.5
  • 42
    • 0026410610 scopus 로고
    • The diagnostic performance of computer programs for the interpretation of electrocardiograms
    • Willems JL, Abreu-Lima C, Arnaud P, et al. The diagnostic performance of computer programs for the interpretation of electrocardiograms. N Engl J Med. 1991;325:1767-73.
    • (1991) N Engl J Med. , vol.325 , pp. 1767-1773
    • Willems, J.L.1    Abreu-Lima, C.2    Arnaud, P.3
  • 43
    • 0028506597 scopus 로고
    • Costs and benefits of picture archiving and communication systems
    • Becker SH, Arenson RL. Costs and benefits of picture archiving and communication systems. J Am Med Inform Assoc. 1994;1:361-71.
    • (1994) J Am Med Inform Assoc. , vol.1 , pp. 361-371
    • Becker, S.H.1    Arenson, R.L.2
  • 44
    • 0031136464 scopus 로고    scopus 로고
    • The barriers to electronic medical record systems and how to overcome them
    • McDonald CJ. The barriers to electronic medical record systems and how to overcome them. JAMIA. 1997;4:222-32.
    • (1997) JAMIA , vol.4 , pp. 222-232
    • McDonald, C.J.1
  • 45
    • 0347165500 scopus 로고    scopus 로고
    • Medical hardware and software buyer's guide
    • Slack W (ed). Medical hardware and software buyer's guide. MD Comput. 1996;13:485-576.
    • (1996) MD Comput. , vol.13 , pp. 485-576
    • Slack, W.1
  • 47
    • 0028367411 scopus 로고
    • Designing medical informatics research and library-resource projects to increase what is learned
    • Stead WW, Haynes RB, Fuller SL, et al. Designing medical informatics research and library-resource projects to increase what is learned. J Am Med Inform Assoc. 1994;1: 28-34.
    • (1994) J Am Med Inform Assoc. , vol.1 , pp. 28-34
    • Stead, W.W.1    Haynes, R.B.2    Fuller, S.L.3
  • 49
    • 0025789555 scopus 로고
    • Obligations of the expert system builder: Meeting the needs of the user
    • Schoolman HM. Obligations of the expert system builder: meeting the needs of the user. MD Comput. 1991;8:316-21.
    • (1991) MD Comput. , vol.8 , pp. 316-321
    • Schoolman, H.M.1
  • 50
    • 0026408583 scopus 로고
    • A strategy for development of computerized critical care decision support systems
    • East TD, Morris AH, Wallace CJ, et al. A strategy for development of computerized critical care decision support systems. Intl J Clin Monit Comput. 1992;8:263-9.
    • (1992) Intl J Clin Monit Comput. , vol.8 , pp. 263-269
    • East, T.D.1    Morris, A.H.2    Wallace, C.J.3
  • 51
    • 0025579695 scopus 로고
    • Why the standard view is standard: People, not machines, understand patients' problems
    • Miller RA. Why the standard view is standard: people, not machines, understand patients' problems. J Med Philos. 1990;15:581-91.
    • (1990) J Med Philos. , vol.15 , pp. 581-591
    • Miller, R.A.1
  • 52
    • 0021978638 scopus 로고
    • Ethical and legal issues related to the use of computer programs in clinical medicine
    • Miller RA, Schaffner KF, Meisel A. Ethical and legal issues related to the use of computer programs in clinical medicine. Ann Intern Med. 1985;102:529-36.
    • (1985) Ann Intern Med. , vol.102 , pp. 529-536
    • Miller, R.A.1    Schaffner, K.F.2    Meisel, A.3
  • 53
    • 85033101447 scopus 로고    scopus 로고
    • Public Law 94-295. Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (passed on May 28, 1976)
    • Public Law 94-295. Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (passed on May 28, 1976).
  • 54
    • 0023318979 scopus 로고
    • Validation of medical software: Present policy of the Food and Drug Administration
    • Young FE. Validation of medical software: present policy of the Food and Drug Administration. Ann Intern Med. 1987; 106:628-29.
    • (1987) Ann Intern Med. , vol.106 , pp. 628-629
    • Young, F.E.1
  • 55
    • 85033120290 scopus 로고
    • Issued September 20
    • FDA Center for Biologics Evaluation and Research, Office of Blood Research and Review, Office of Compliance, Office of Regulatory Affairs. Draft Guideline for the Validation of Blood Establishment of Computer Systems. Issued September 20, 1994. Available from FDA WWW Site: http:// www.fda.gov
    • (1994) Draft Guideline for the Validation of Blood Establishment of Computer Systems
  • 58
    • 0347795535 scopus 로고    scopus 로고
    • Issued July 11
    • FDA Center for Devices and Radiological Health. Telemedicine Related Activities. Issued July 11, 1996. Available from FDA WWW Site: http://www.fda.gov//cdrh/telemed.html
    • (1996) Telemedicine Related Activities
  • 62
    • 85033120329 scopus 로고    scopus 로고
    • Organization for International Standards. ISO 9000 News Service, 1996-97. Documentation available from: http:// www.iso.ch
    • ISO 9000 News Service, 1996-97
  • 63
    • 0028367221 scopus 로고
    • Standards for medical identifiers, codes, and messages needed to create an efficient computer-stored record
    • AMIA Board of Directors. Standards for medical identifiers, codes, and messages needed to create an efficient computer-stored record. J Am Med Inform Assoc. 1994;1:1-7.
    • (1994) J Am Med Inform Assoc. , vol.1 , pp. 1-7


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.