Jeff Collmann

A Heuristic Indication and Warning Staging Model for Detection and Assessment of Biological Events

Abstract Objective This paper presents a model designed to enable rapid detection and assessment of biological threats that may require swift intervention by the international public health community. Design We utilized Strauss’ grounded theory to develop an expanded model of social disruption due to biological events based on retrospective and prospective case studies. We then applied this model to the temporal domain and propose a heuristic staging model, the Wilson–Collmann Scale for assessing biological event evolution. Measurements We retrospectively and manually examined hard copy archival local media reports in the native vernacular for three biological events associated with substantial social disruption. The model was then tested prospectively through media harvesting based on keywords corresponding to the model parameters. Results Our heuristic staging model provides valuable information about the features of a biological event that can be used to determine the level of concern warranted, such as whether the pathogen in question is responding to established public health disease control measures, including the use of antimicrobials or vaccines; whether the public health and medical infrastructure of the country involved is adequate to mount the necessary response; whether the country’s officials are providing an appropriate level of information to international public health authorities; and whether the event poses a international threat. The approach is applicable for monitoring open-source (public-domain) media for indications and warnings of such events, and specifically for markers of the social disruption that commonly occur as these events unfold. These indications and warnings can then be used as the basis for staging the biological threat in the same manner that the United States National Weather Service currently uses storm warning models (such as the Saffir-Simpson Hurricane Scale) to detect and assess threatening weather conditions. Conclusion Used as a complement to current epidemiological surveillance methods, our approach could aid global public health officials and national political leaders in responding to biological threats of international public health significance.

Hemodialysis Patient Management by Telemedicine: Design and Implementation

The authors describe the design and implementation of a personal computer based telemedicine system for managing patients by telemedicine. With three identical systems connected by high speed T1 lines, the physician (or allied healthcare giver) can interact, by videoconferencing, and by using multimedia files, with patients at two remote hemodialysis sites. The physician is able to visualize specifically the patients fistula/graft, and auscultate fistula, heart and lung sounds, and incorporate still pictures or audio sounds in the patients multimedia database folder, which also contains an electronic and paperless medical record. In addition there is the capability of downloading into this database all the machine parameters during dialysis. ASAIO Journal 1997; 43:M763-M766.

Media attitudes vs. use: the contribution of context to the communication environment in telemedicine.

Media attitudes and media use have been the focus of considerable academic research. This article uses this research to explore patient and health care practitioner attitudes toward telemedicine interactions via videoconferencing technology.

Organizational repertoires and rites in health information security.

The privacy and security rules of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 emphasize taking steps for protecting protected health information from unauthorized access and modification. Nonetheless, even organizations highly skilled in data security that comply with regulations and all good practices will suffer and must respond to breaches. This paper reports on a case study in responding to an important breach of the confidentiality and integrity of identifiable patient information of the Kaiser Internet Patient Portal known as “Kaiser Permanente Online” (KP Online). From the perspective of theories about highly reliable organizations, effective health information security programs must respond resiliently to as well as prospectively anticipate security breaches.

The executive summary of the National Forum on the Future of Defense Health Information Systems.

The Department of Defense (DoD) has been engaged in the development and deployment of the longitudinal health record (LHR). It has achieved remarkable technological success by handling vast amounts of patient data coming from clinical sites around the globe. Interoperability between DoD and VA has improved and this information sharing capability is expected to continue to expand as the defense health information system becomes an integral part of the national network. On the other hand, significant challenges remain in terms of user acceptance, ability to incorporate innovations, software acquisition methodology, and overall systems architecture.

Comparing the security risks of paper-based and computerized patient record systems

How should hospital administrators compare the security risks of paper-based and computerized patient record systems. There is a general tendency to assume that because computer networks potentially provide broad access to hospital archives, computerized patient records are less secure than paper records and increase the risk of breaches of patient confidentiality. This assumption is ill-founded on two grounds. Reasons exist to say that the computerized patient record provides better access to patient information while enhancing overall information system security. A range of options with different trade-offs between access and security exist in both paper-based and computerized records management systems. The relative accessibility and security of any particular patient record management system depends, therefore, on administrative choice, not simply on the intrinsic features of paper or computerized information management systems.

Reflecting on the ethical administration of computerized medical records

This presentation examines the ethical issues raised by computerized image management and communication systems (IMAC), the ethical principals that should guide development of policies, procedures and practices for IMACS systems, and who should be involved in developing a hospitals approach to these issues. The ready access of computerized records creates special hazards of which hospitals must beware. Hospitals must maintain confidentiality of patients records while making records available to authorized users as efficiently as possible. The general conditions of contemporary health care undermine protecting the confidentiality of patient record. Patients may not provide health care institutions with information about themselves under conditions of informed consent. The field of information science must design sophisticated systems of computer security that stratify access, create audit trails on data changes and system use, safeguard patient data from corruption, and protect the databases from outside invasion. Radiology professionals must both work with information science experts in their own hospitals to create institutional safeguards and include the adequacy of security measures as a criterion for evaluating PACS systems. New policies and procedures on maintaining computerized patient records must be developed that obligate all members of the health care staff, not just care givers. Patients must be informed about the existence of computerized medical records, the rules and practices that govern their dissemination and given the opportunity to give or withhold consent for their use. Departmental and hospital policies on confidentiality should be reviewed to determine if revisions are necessary to manage computer-based records. Well developed discussions of the ethical principles and administrative policies on confidentiality and informed consent and of the risks posed by computer-based patient records systems should be included in initial and continuing staff system training. Administration should develop ways to monitor staff compliance with confidentiality policies and should assess diligence in maintaining patient record confidentiality as part of staff annual performance evaluations. Ethical management of IMAC systems is the business of all members of the health care team. Computerized patient records management (including IMAC) should be scrutinized as any other clinical medial ethical issue. If hospitals include these processes in their planning for RIS, IMACS, and HIS systems, they should have time to develop institutional expertise on these questions before and as systems are installed rather than only as ethical dilemmas develop during their use.

Data Management Plans, Institutional Review Boards, and the Ethical Management of Big Data About Human Subjects

This chapter offers investigators a set of decision trees with detailed case examples to help them prepare Data Management Plans (DMP) that address ethical and information protection issues in big data research projects. It opens with an explanation of the 4Rs of big data research that is, reuse, repurposing, recombination and reanalysis. The 4Rs highlight the importance of ethical provence and ethical horizon; that is, the ethical implications of the possibility that investigators using big data for human research will draw their sources from pre-existing data from multiple kinds of sources and that other investigators will use their data in subsequent studies. The DMP decision tree encourages investigators to reflect on the ethical status of any consent provided by the human subjects under consideration, if known or potentially known, for both existing data and data proposed for collection. The decision tree also encourages investigators to reflect on the range of ethical implications of their research, including potential benefits and harms as well as implications for individual and group autonomy, social justice and trust in the institution of science. We offer the DMP decision tree as a tool to help investigators and their organizations become more adept in assessing the privacy and ethical risks of big data research with human subjects and, thus, ensure the public’s acceptance and participation in the projects they plan for the future. Working through the steps of the decision trees also highlights the need for investigators to seek counsel from various institutional resources relevant to protecting human subjects and their information in big data research, particularly their organization’s Institutional Review Board, office of general counsel, and computer security staff. From this perspective, we urge caution against downgrading the role of such organizations in managing human subjects research in big data until the scientific community as a whole has more experience with its complexities.

Embedding Privacy and Ethical Values in Big Data Technology

The phenomenon now commonly referred to as “Big Data” holds great promise and opportunity as a potential source of solutions to many societal ills ranging from cancer to terrorism; but it might also end up as “…a troubling manifestation of Big Brother, enabling invasions of privacy, decreased civil freedoms (and) increased state and corporate control” (Boyd & Crawford, 2012, p. 664). Discussions about the use of Big Data are widespread as “(d)iverse groups argue about the potential benefits and costs of analyzing genetic sequences, social media interactions, health records, phone logs, government records, and other digital traces left by people” (Boyd & Crawford, 2012, p. 662). This chapter attempts to establish guidelines for the discussion and analysis of ethical issues related to Big Data in research, particularly with respect to privacy. In doing so, it adds new dimensions to the agenda setting goal of this volume. It is intended to help researchers in all fields, as well as policy-makers, to articulate their concerns in an organized way, and to specify relevant issues for discussion, policy-making and action with respect to the ethics of Big Data. On the basis of our review of scholarly literature and our own investigations with big and small data, we have come to recognize that privacy and the great potential for privacy violations constitute major concerns in the debate about Big Data. Furthermore, our approach and our recommendations are generalizable to other ethical considerations inherent in Big Data as we illustrate in the final section of the chapter.

A Theoretical Framework for Ethical Reflection in Big Data Research

The emergence of massive datasets collected using automated or large scale data harvesting methodologies ushered in by digital tools creates new challenges for researchers with respect to the ethical use and securing of private information. Such concerns are heightened by the fact that big data is likely to be reused, reanalyzed, recombined, and repurposed without explicit consent from the original data providers. The present chapter offers a methodology for assessing the ethical nature of a given big data use situation. The approach is contextual and relational. Researchers are invited to use a privacy matrix that intersects five ethical concerns (non-maleficence, beneficence, justice, autonomy, and trust) with four possible contexts of use (social, science, government, and science). The matrix can be used to determine the significance of the ethical problem for a given situation by tallying the number and assessing the nature of concerns present in using the data in a given context. Furthermore, the heuristic procedure can be enhanced with a modified type of trade-off analysis which starts from a minimum ethical threshold below which trade-offs should not be performed. The matrix and the heuristic method offer a pragmatic, yet ethically grounded approach to dealing with the complex nature of privacy in the context of big data research.