Legal perspectives on black box recording devices in the operating environment
Background A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surg...
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| Veröffentlicht in: | British journal of surgery 2019-10, Vol.106 (11), p.1433-1441 |
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| creator | Dalen, A. S. H. M. Legemaate, J. Schlack, W. S. Legemate, D. A. Schijven, M. P. |
| description | Background
A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surgical environment, are presented in this narrative review.
Methods
A review of PubMed and Embase databases and Cochrane Library was undertaken. International jurisprudence on the topic was searched. Practice recommendations and legal perspectives were acquired based on experience with implementation and use of a video and medical data recorder in the operating theatre.
Results
After removing duplicates, 116 citations were retrieved and s screened; 31 articles were assessed for eligibility and 20 papers were finally included. According to the European General Data Protection Regulation and US Health Insurance Portability and Accountability Act, researchers are required to make sure that personal data collected from patients and healthcare professionals are used fairly and lawfully, for limited and specifically stated purposes, in an adequate and relevant manner, kept safe and secure, and stored for no longer than is absolutely necessary. Data collected for the sole purpose of healthcare quality improvement are not required to be added to the patient's medical record.
Conclusion
Transparency on the use and purpose of recorded data should be ensured to both staff and patients. The recorded video data do not need to be used as evidence in court if patient medical records are well maintained. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.
Antecedentes
Es posible instalar un sistema de video y grabación de datos médicos en el quirófano, pero su implementación se ha visto limitada por las dudas relativas a la privacidad, uso de datos y aspectos de litigio. Estas dudas deberían superarse, motivo por el que en este trabajo se proponen unas guías sobre el uso de sistemas de registro en el ambiente quirúrgico.
Métodos
Se realizó una revisión en las bases de datos Pubmed y Embase y de la Biblioteca Cochrane. Se buscó la jurisprudencia internacional sobre el tema. Se establecieron unas recomendaciones prácticas y de las perspectivas legales adquiridas a través de la experiencia de la implementación y el uso de sistemas de video y registro de datos médicos en el quirófano.
Resultados
Se obtuvieron 1 |
| doi_str_mv | 10.1002/bjs.11198 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6790687</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2232067493</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4098-476c94161b99d0fbd9537a332c06229c5d38ca7220d6d90f129840f41d15eca53</originalsourceid><addsrcrecordid>eNpdkc1OGzEUhS1EBSllwQugkdiwmeRee8Yz3iBBVPqjCBZt15bHdoLDxA72JIW3rwMU0a58pfPd42MfQk4QxghAJ90yjRFRtHtkhIzXJUXe7pMRADQlMsoOyceUlgDIoKYH5JBlmlJRjcjNzC5UX6xtTGurB7e1qQi-6Hql74suPBbR6hCN84vC2K3TWXa-GO5sEfKOGnaC9VsXg19ZP3wiH-aqT_b49Twiv64__5x-LWe3X75NL2elrkC0ZdVwLSrk2AlhYN4ZUbNGMUY18JxL14a1WjWUguFGwBypaCuYV2iwtlrV7IhcvPiuN93KGp2vjqqX6-hWKj7JoJz8V_HuTi7CVvJGAG-bbHD-ahDDw8amQa5c0rbvlbdhkySljAJvKsEyevYfugyb6PPzMiUEb1tAzNTp-0RvUf5-dQYmL8Bv19unNx1B7jqUuUP53KG8-v7jeWB_AFOijfU</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2299688011</pqid></control><display><type>article</type><title>Legal perspectives on black box recording devices in the operating environment</title><source>MEDLINE</source><source>Access via Wiley Online Library</source><source>Oxford University Press Journals All Titles (1996-Current)</source><creator>Dalen, A. S. H. M. ; Legemaate, J. ; Schlack, W. S. ; Legemate, D. A. ; Schijven, M. P.</creator><creatorcontrib>Dalen, A. S. H. M. ; Legemaate, J. ; Schlack, W. S. ; Legemate, D. A. ; Schijven, M. P.</creatorcontrib><description>Background
A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surgical environment, are presented in this narrative review.
Methods
A review of PubMed and Embase databases and Cochrane Library was undertaken. International jurisprudence on the topic was searched. Practice recommendations and legal perspectives were acquired based on experience with implementation and use of a video and medical data recorder in the operating theatre.
Results
After removing duplicates, 116 citations were retrieved and s screened; 31 articles were assessed for eligibility and 20 papers were finally included. According to the European General Data Protection Regulation and US Health Insurance Portability and Accountability Act, researchers are required to make sure that personal data collected from patients and healthcare professionals are used fairly and lawfully, for limited and specifically stated purposes, in an adequate and relevant manner, kept safe and secure, and stored for no longer than is absolutely necessary. Data collected for the sole purpose of healthcare quality improvement are not required to be added to the patient's medical record.
Conclusion
Transparency on the use and purpose of recorded data should be ensured to both staff and patients. The recorded video data do not need to be used as evidence in court if patient medical records are well maintained. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.
Antecedentes
Es posible instalar un sistema de video y grabación de datos médicos en el quirófano, pero su implementación se ha visto limitada por las dudas relativas a la privacidad, uso de datos y aspectos de litigio. Estas dudas deberían superarse, motivo por el que en este trabajo se proponen unas guías sobre el uso de sistemas de registro en el ambiente quirúrgico.
Métodos
Se realizó una revisión en las bases de datos Pubmed y Embase y de la Biblioteca Cochrane. Se buscó la jurisprudencia internacional sobre el tema. Se establecieron unas recomendaciones prácticas y de las perspectivas legales adquiridas a través de la experiencia de la implementación y el uso de sistemas de video y registro de datos médicos en el quirófano.
Resultados
Se obtuvieron 116 referencias, de las que una vez eliminadas las duplicadas (n = 5) y revisados los resumenes, 31 artículos cumplían los criterios de eligibilidad. En el estudio final se incluyeron 20 artículos. De acuerdo con la Ley Orgánica de Protección de Datos (General Data Protection Regulation, GDRP) y la Ley de Transferencia y Responsabilidad de Seguro Médico (Health Insurance Portability and Accountability Act, HIPAA), los investigadores deben asegurar que los datos personales recopilados pertenecientes a los pacientes y profesionales de la salud se utilicen de manera justa y legal, con fines definidos y bien establecidos, de manera adecuada y relevante, y mantenidos a resguardo y almacenados no más tiempo del estrictamente necesario. No es necesario que los datos recopilados con el único propósito de mejorar la calidad de la atención médica se agreguen a la historia clínica del paciente.
Conclusión
Se debe asegurar por parte del personal sanitario como del paciente, la transparencia tanto en la utilización como en el objetivo de los datos almacenados. Los datos registrados en video no es necesario que sean usados como evidencia en procesos judiciales si la historia clínica de los pacientes cumple los estandares establecidos. Se precisa una legislación clara sobre la responsabilidad de los datos para la utilización óptima de los registros médicos en las iniciativas de mejora de la calidad.
A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. Transparency on the use and purpose of the recorded data should be ensured to both staff and patients. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.
Coming to a theatre near you</description><identifier>ISSN: 0007-1323</identifier><identifier>EISSN: 1365-2168</identifier><identifier>DOI: 10.1002/bjs.11198</identifier><identifier>PMID: 31112294</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Ltd</publisher><subject><![CDATA[Accountability ; General Data Protection Regulation ; Health Insurance Portability & Accountability Act 1996-US ; Humans ; Medical Errors - legislation & jurisprudence ; Medical records ; Operating Rooms - legislation & jurisprudence ; Patient Safety - legislation & jurisprudence ; Privacy ; Review ; Reviews ; Safety Management - legislation & jurisprudence ; Surgical Procedures, Operative - legislation & jurisprudence ; Video Recording - legislation & jurisprudence]]></subject><ispartof>British journal of surgery, 2019-10, Vol.106 (11), p.1433-1441</ispartof><rights>2019 The Authors. published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.</rights><rights>2019 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.</rights><rights>2019. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4098-476c94161b99d0fbd9537a332c06229c5d38ca7220d6d90f129840f41d15eca53</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fbjs.11198$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fbjs.11198$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,315,781,785,886,1418,27929,27930,45579,45580</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31112294$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dalen, A. S. H. M.</creatorcontrib><creatorcontrib>Legemaate, J.</creatorcontrib><creatorcontrib>Schlack, W. S.</creatorcontrib><creatorcontrib>Legemate, D. A.</creatorcontrib><creatorcontrib>Schijven, M. P.</creatorcontrib><title>Legal perspectives on black box recording devices in the operating environment</title><title>British journal of surgery</title><addtitle>Br J Surg</addtitle><description>Background
A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surgical environment, are presented in this narrative review.
Methods
A review of PubMed and Embase databases and Cochrane Library was undertaken. International jurisprudence on the topic was searched. Practice recommendations and legal perspectives were acquired based on experience with implementation and use of a video and medical data recorder in the operating theatre.
Results
After removing duplicates, 116 citations were retrieved and s screened; 31 articles were assessed for eligibility and 20 papers were finally included. According to the European General Data Protection Regulation and US Health Insurance Portability and Accountability Act, researchers are required to make sure that personal data collected from patients and healthcare professionals are used fairly and lawfully, for limited and specifically stated purposes, in an adequate and relevant manner, kept safe and secure, and stored for no longer than is absolutely necessary. Data collected for the sole purpose of healthcare quality improvement are not required to be added to the patient's medical record.
Conclusion
Transparency on the use and purpose of recorded data should be ensured to both staff and patients. The recorded video data do not need to be used as evidence in court if patient medical records are well maintained. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.
Antecedentes
Es posible instalar un sistema de video y grabación de datos médicos en el quirófano, pero su implementación se ha visto limitada por las dudas relativas a la privacidad, uso de datos y aspectos de litigio. Estas dudas deberían superarse, motivo por el que en este trabajo se proponen unas guías sobre el uso de sistemas de registro en el ambiente quirúrgico.
Métodos
Se realizó una revisión en las bases de datos Pubmed y Embase y de la Biblioteca Cochrane. Se buscó la jurisprudencia internacional sobre el tema. Se establecieron unas recomendaciones prácticas y de las perspectivas legales adquiridas a través de la experiencia de la implementación y el uso de sistemas de video y registro de datos médicos en el quirófano.
Resultados
Se obtuvieron 116 referencias, de las que una vez eliminadas las duplicadas (n = 5) y revisados los resumenes, 31 artículos cumplían los criterios de eligibilidad. En el estudio final se incluyeron 20 artículos. De acuerdo con la Ley Orgánica de Protección de Datos (General Data Protection Regulation, GDRP) y la Ley de Transferencia y Responsabilidad de Seguro Médico (Health Insurance Portability and Accountability Act, HIPAA), los investigadores deben asegurar que los datos personales recopilados pertenecientes a los pacientes y profesionales de la salud se utilicen de manera justa y legal, con fines definidos y bien establecidos, de manera adecuada y relevante, y mantenidos a resguardo y almacenados no más tiempo del estrictamente necesario. No es necesario que los datos recopilados con el único propósito de mejorar la calidad de la atención médica se agreguen a la historia clínica del paciente.
Conclusión
Se debe asegurar por parte del personal sanitario como del paciente, la transparencia tanto en la utilización como en el objetivo de los datos almacenados. Los datos registrados en video no es necesario que sean usados como evidencia en procesos judiciales si la historia clínica de los pacientes cumple los estandares establecidos. Se precisa una legislación clara sobre la responsabilidad de los datos para la utilización óptima de los registros médicos en las iniciativas de mejora de la calidad.
A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. Transparency on the use and purpose of the recorded data should be ensured to both staff and patients. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.
Coming to a theatre near you</description><subject>Accountability</subject><subject>General Data Protection Regulation</subject><subject>Health Insurance Portability & Accountability Act 1996-US</subject><subject>Humans</subject><subject>Medical Errors - legislation & jurisprudence</subject><subject>Medical records</subject><subject>Operating Rooms - legislation & jurisprudence</subject><subject>Patient Safety - legislation & jurisprudence</subject><subject>Privacy</subject><subject>Review</subject><subject>Reviews</subject><subject>Safety Management - legislation & jurisprudence</subject><subject>Surgical Procedures, Operative - legislation & jurisprudence</subject><subject>Video Recording - legislation & jurisprudence</subject><issn>0007-1323</issn><issn>1365-2168</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><recordid>eNpdkc1OGzEUhS1EBSllwQugkdiwmeRee8Yz3iBBVPqjCBZt15bHdoLDxA72JIW3rwMU0a58pfPd42MfQk4QxghAJ90yjRFRtHtkhIzXJUXe7pMRADQlMsoOyceUlgDIoKYH5JBlmlJRjcjNzC5UX6xtTGurB7e1qQi-6Hql74suPBbR6hCN84vC2K3TWXa-GO5sEfKOGnaC9VsXg19ZP3wiH-aqT_b49Twiv64__5x-LWe3X75NL2elrkC0ZdVwLSrk2AlhYN4ZUbNGMUY18JxL14a1WjWUguFGwBypaCuYV2iwtlrV7IhcvPiuN93KGp2vjqqX6-hWKj7JoJz8V_HuTi7CVvJGAG-bbHD-ahDDw8amQa5c0rbvlbdhkySljAJvKsEyevYfugyb6PPzMiUEb1tAzNTp-0RvUf5-dQYmL8Bv19unNx1B7jqUuUP53KG8-v7jeWB_AFOijfU</recordid><startdate>201910</startdate><enddate>201910</enddate><creator>Dalen, A. S. H. M.</creator><creator>Legemaate, J.</creator><creator>Schlack, W. S.</creator><creator>Legemate, D. A.</creator><creator>Schijven, M. P.</creator><general>John Wiley & Sons, Ltd</general><general>Oxford University Press</general><scope>24P</scope><scope>WIN</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201910</creationdate><title>Legal perspectives on black box recording devices in the operating environment</title><author>Dalen, A. S. H. M. ; Legemaate, J. ; Schlack, W. S. ; Legemate, D. A. ; Schijven, M. P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4098-476c94161b99d0fbd9537a332c06229c5d38ca7220d6d90f129840f41d15eca53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Accountability</topic><topic>General Data Protection Regulation</topic><topic>Health Insurance Portability & Accountability Act 1996-US</topic><topic>Humans</topic><topic>Medical Errors - legislation & jurisprudence</topic><topic>Medical records</topic><topic>Operating Rooms - legislation & jurisprudence</topic><topic>Patient Safety - legislation & jurisprudence</topic><topic>Privacy</topic><topic>Review</topic><topic>Reviews</topic><topic>Safety Management - legislation & jurisprudence</topic><topic>Surgical Procedures, Operative - legislation & jurisprudence</topic><topic>Video Recording - legislation & jurisprudence</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dalen, A. S. H. M.</creatorcontrib><creatorcontrib>Legemaate, J.</creatorcontrib><creatorcontrib>Schlack, W. S.</creatorcontrib><creatorcontrib>Legemate, D. A.</creatorcontrib><creatorcontrib>Schijven, M. P.</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library (Open Access Collection)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dalen, A. S. H. M.</au><au>Legemaate, J.</au><au>Schlack, W. S.</au><au>Legemate, D. A.</au><au>Schijven, M. P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Legal perspectives on black box recording devices in the operating environment</atitle><jtitle>British journal of surgery</jtitle><addtitle>Br J Surg</addtitle><date>2019-10</date><risdate>2019</risdate><volume>106</volume><issue>11</issue><spage>1433</spage><epage>1441</epage><pages>1433-1441</pages><issn>0007-1323</issn><eissn>1365-2168</eissn><abstract>Background
A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surgical environment, are presented in this narrative review.
Methods
A review of PubMed and Embase databases and Cochrane Library was undertaken. International jurisprudence on the topic was searched. Practice recommendations and legal perspectives were acquired based on experience with implementation and use of a video and medical data recorder in the operating theatre.
Results
After removing duplicates, 116 citations were retrieved and s screened; 31 articles were assessed for eligibility and 20 papers were finally included. According to the European General Data Protection Regulation and US Health Insurance Portability and Accountability Act, researchers are required to make sure that personal data collected from patients and healthcare professionals are used fairly and lawfully, for limited and specifically stated purposes, in an adequate and relevant manner, kept safe and secure, and stored for no longer than is absolutely necessary. Data collected for the sole purpose of healthcare quality improvement are not required to be added to the patient's medical record.
Conclusion
Transparency on the use and purpose of recorded data should be ensured to both staff and patients. The recorded video data do not need to be used as evidence in court if patient medical records are well maintained. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.
Antecedentes
Es posible instalar un sistema de video y grabación de datos médicos en el quirófano, pero su implementación se ha visto limitada por las dudas relativas a la privacidad, uso de datos y aspectos de litigio. Estas dudas deberían superarse, motivo por el que en este trabajo se proponen unas guías sobre el uso de sistemas de registro en el ambiente quirúrgico.
Métodos
Se realizó una revisión en las bases de datos Pubmed y Embase y de la Biblioteca Cochrane. Se buscó la jurisprudencia internacional sobre el tema. Se establecieron unas recomendaciones prácticas y de las perspectivas legales adquiridas a través de la experiencia de la implementación y el uso de sistemas de video y registro de datos médicos en el quirófano.
Resultados
Se obtuvieron 116 referencias, de las que una vez eliminadas las duplicadas (n = 5) y revisados los resumenes, 31 artículos cumplían los criterios de eligibilidad. En el estudio final se incluyeron 20 artículos. De acuerdo con la Ley Orgánica de Protección de Datos (General Data Protection Regulation, GDRP) y la Ley de Transferencia y Responsabilidad de Seguro Médico (Health Insurance Portability and Accountability Act, HIPAA), los investigadores deben asegurar que los datos personales recopilados pertenecientes a los pacientes y profesionales de la salud se utilicen de manera justa y legal, con fines definidos y bien establecidos, de manera adecuada y relevante, y mantenidos a resguardo y almacenados no más tiempo del estrictamente necesario. No es necesario que los datos recopilados con el único propósito de mejorar la calidad de la atención médica se agreguen a la historia clínica del paciente.
Conclusión
Se debe asegurar por parte del personal sanitario como del paciente, la transparencia tanto en la utilización como en el objetivo de los datos almacenados. Los datos registrados en video no es necesario que sean usados como evidencia en procesos judiciales si la historia clínica de los pacientes cumple los estandares establecidos. Se precisa una legislación clara sobre la responsabilidad de los datos para la utilización óptima de los registros médicos en las iniciativas de mejora de la calidad.
A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. Transparency on the use and purpose of the recorded data should be ensured to both staff and patients. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.
Coming to a theatre near you</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>31112294</pmid><doi>10.1002/bjs.11198</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 0007-1323 |
| ispartof | British journal of surgery, 2019-10, Vol.106 (11), p.1433-1441 |
| issn | 0007-1323 1365-2168 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6790687 |
| source | MEDLINE; Access via Wiley Online Library; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Accountability General Data Protection Regulation Health Insurance Portability & Accountability Act 1996-US Humans Medical Errors - legislation & jurisprudence Medical records Operating Rooms - legislation & jurisprudence Patient Safety - legislation & jurisprudence Privacy Review Reviews Safety Management - legislation & jurisprudence Surgical Procedures, Operative - legislation & jurisprudence Video Recording - legislation & jurisprudence |
| title | Legal perspectives on black box recording devices in the operating environment |
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