Software, risks, and liabilities: ongoing and emergent issues in 3D bioprinting

The growing use of software in biomedicine has enlarged the capacities of researchers and clinicians. This, one might expect, would enhance the precision and safety of biomedicine. However, it has ...

[1]  Katie J. Ward,et al.  A Sociology of Technology Governance for the Information Age: The Case of Pharmaceuticals, Consumer Advertising and the Internet , 2006 .

[2]  B Sibbald,et al.  A subtle governance: 'soft' medical leadership in English primary care. , 2003, Sociology of health & illness.

[3]  Martin Heller,et al.  Social and legal frame conditions for 3D (and) bioprinting in medicine. , 2016, International journal of computerized dentistry.

[4]  Andrew Bartlett,et al.  Inscribing a discipline: tensions in the field of bioinformatics , 2013 .

[5]  Rui Yao,et al.  Bioprinting of Stem Cells: Interplay of Bioprinting Process, Bioinks, and Stem Cell Properties. , 2018, ACS biomaterials science & engineering.

[6]  Andras Czirok,et al.  Software tools for cell culture-related 3D printed structures , 2018, PloS one.

[7]  L. Stoletniy,et al.  A practical guide to cardiovascular 3D printing in clinical practice: Overview and examples , 2018, Journal of interventional cardiology.

[8]  Vladimir Mironov,et al.  Organ printing: promises and challenges. , 2008, Regenerative medicine.

[9]  Vidya Atal,et al.  Developers' Incentives and Open Source Software Licensing: GPL vs. BSD , 2015 .

[10]  M P Young,et al.  Brain structure-function relationships: advances from neuroinformatics. , 2000, Philosophical transactions of the Royal Society of London. Series B, Biological sciences.

[11]  Alex Faulkner.  Bioinformatics imaginaries in the engine-room of genomic health policy: , 2017 .

[12]  B. Chaffin,et al.  A Decade of Adaptive Governance Scholarship: Synthesis and Future Directions , 2014 .

[13]  Alex Faulkner,et al.  Medical Technology into Healthcare and Society: A Sociology of Devices, Innovation and Governance , 2008 .

[14]  N C Andreasen,et al.  Functional MRI statistical software packages: A comparative analysis , 1998, Human brain mapping.

[15]  Edison Bicudo.  Neuroimaging, Software, and Communication , 2019, Springer Singapore.

[16]  Michael Schmitt,et al.  Neuroimaging databases as a resource for scientific discovery. , 2005, International review of neurobiology.

[17]  Maximiliano S. Perez,et al.  Development of image analysis software for quantification of viable cells in microchips , 2018, PloS one.

[18]  Benjamin Cashore,et al.  Legitimacy and the Privatization of Environmental Governance: How Non–State Market–Driven (NSMD) Governance Systems Gain Rule–Making Authority , 2002 .

[19]  B Beier,et al.  Liability and responsibility for clinical software in the Federal Republic of Germany. , 1987, Computer methods and programs in biomedicine.

[20]  Jos Vander Sloten,et al.  Computer aided design of prostheses , 1998 .

[21]  Sergey Y Turin,et al.  Advances in oncologic head and neck reconstruction: systematic review and future considerations of virtual surgical planning and computer aided design/computer aided modeling. , 2014, Journal of plastic, reconstructive & aesthetic surgery : JPRAS.

[22]  Charlotte Salter,et al.  Bioinformatics and the Politics of Innovation in the Life Sciences , 2016, Science, technology & human values.

[23]  Edna Suárez-Díaz,et al.  Making room for new faces: evolution, genomics and the growth of bioinformatics. , 2010, History and philosophy of the life sciences.

[24]  Ali Khademhosseini,et al.  A perspective on 3D bioprinting in tissue regeneration , 2018, Bio-design and manufacturing.

[25]  K Howard,et al.  The bioinformatics gold rush. , 2000, Scientific American.

[26]  Stephen H. Koslow,et al.  Neuroinformatics as a megascience issue , 1999, IEEE Transactions on Information Technology in Biomedicine.

[27]  D Luzi,et al.  The integration of the risk management process with the lifecycle of medical device software. , 2014, Methods of information in medicine.

[28]  Phoebe Li,et al.  3D Bioprinting Regulations: a UK/EU Perspective , 2017, European Journal of Risk Regulation.

[29]  Amit Prasad,et al.  Making Images/Making Bodies: Visibilizing and Disciplining through Magnetic Resonance Imaging (MRI) , 2005 .

[30]  G. Henderson,et al.  Neglected ethical issues in biobank management: Results from a U.S. study , 2013, Life Sciences, Society and Policy.

[31]  Norman F. Schneidewind.  SOFTWARE RISK ANALYSIS , 2009 .

[32]  Michael Schwarz,et al.  Half a Century of Public Software Institutions: Open Source as a Solution to Hold-Up Problem , 2009 .

[33]  Vladimir Mironov,et al.  Organ printing: computer-aided jet-based 3D tissue engineering. , 2003, Trends in biotechnology.

[34]  Michel Quéré,et al.  The Governance of Interactive Learning within Innovation Systems , 2002 .

[35]  A Beaulieu,et al.  Voxels in the Brain , 2001, Social studies of science.

[36]  Robert W. Cox,et al.  AFNI: What a long strange trip it's been , 2012, NeuroImage.

[37]  Steven H. Brown,et al.  Chapter 26 – Legal and Regulatory Issues Related to the Use of Clinical Software in Health Care Delivery , 2014 .

[38]  Phoebe Li,et al.  3D bioprinting in a 2D regulatory landscape: gaps, uncertainties, and problems , 2020 .

[39]  Georg von Krogh,et al.  Open Source Software and the "Private-Collective" Innovation Model: Issues for Organization Science , 2003, Organ. Sci..

[40]  Martin Höst,et al.  Software Risk Analysis in Medical Device Development , 2011, 2011 37th EUROMICRO Conference on Software Engineering and Advanced Applications.

[41]  T M Brown,et al.  Searching for shadows of other earths. , 2000, Scientific American.