The Importance Of Human Factor In Information Security

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The Importance Of Human Factor In Information Security



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The Human Factors in Cybersecurity: Preventing Human Error - CISO Talks

Collectively, these forms of health research have led to significant discoveries, the development of new therapies, and a remarkable improvement in health care and public health. If the research enterprise is impeded, or if it is less robust, important societal interests are affected. The development of Herceptin as a treatment for breast cancer is a prime example of the benefits of research using biological samples and patient records Box Slamon et al. Many other examples of findings from medical records research have changed the practice of medicine as well. Such research underlies the estimate that tens of thousands of Americans die each year from medical errors in the hospital, and research has provided valuable information for reducing these medical errors by implementing health information technology, such as e-prescribing Bates et al.

This type of research also has documented that disparities in health care and lack of access to care in inner cities and rural areas result in poorer health outcomes Mick et al. Furthermore, medical records research has demonstrated that preventive services e. These findings have all informed and influenced policy decisions at the national level. As the use of electronic medical records increases, the pace of this form of research is accelerating, and the opportunities to generate new knowledge about what works in health care are expanding CHSR, Herceptin and breast cancer: Data were collected from a cohort of more than 9, breast cancer patients whose tumor specimens were consecutively received at the University more Advances in health information technology are enabling a transformation in health research that could facilitate studies that were not feasible in the past, and thus lead to new insights regarding health and disease.

The informatics grid recently developed with support from the National Cancer Institute Cancer Biomedical Informatics Grid, or caBIG is an example of a how information technologies can facilitate health research by enabling broader sharing of health data while still ensuring regulatory compliance and protecting patient privacy Box Science today is also changing rapidly and becoming more complex, so no single researcher or single site can bring all the expertise to develop and validate medical innovations or to ensure their safety. Thus, efficient sharing of information between institutions has become even more important than in previous eras, when there were fewer new therapies introduced.

The expansion of treatment options, as well as the escalating expense of new therapies, mandates greater scrutiny of true effectiveness, 5 once efficacy has been demonstrated. This requires registries of patient characteristics, outcomes, and adverse events. Analysis of the data collected is expected to facilitate improved patient evaluation and management while aiding in better device development. Registry results are also expected to influence future research and facilitate appropriate regulation and reimbursement of such devices. Similarly, the Extracorporeal Life Support Organization ELSO , 7 an international consortium of health care professionals and scientists who focus on the development and evaluation of novel therapies for support of failing organ systems, maintains a registry of extracorporeal membrane oxygenation and other novel forms of organ system support.

Registry data are used to support clinical practice and research, as well as regulatory agencies. Another example is the database developed by the United Network for Organ Sharing UNOS for the collection, storage, analysis and publication of data pertaining to the patient waiting list, organ matching, and transplants. Information-based research, such as research using health information databases has many advantages reviewed by Lowrance, It is often faster and less expensive than experimental studies; it can analyze very large sets of data and may detect unexpected phenomena or differences among subpopulations that might not be included in a controlled experimental study; it can often be undertaken when controlled trials are simply not possible for ethical, technical, or other reasons, and it can be used to study effectiveness of a specific test or intervention in clinical practice, rather than just the efficacy as determined by a controlled experimental study.

It can also reexamine data accrued in other research studies, such as clinical trials, to answer new questions quickly and inexpensively. However, information-based research does have limitations. Often it has less statistical rigor than controlled clinical studies because it lacks scientific control over the original data collection, quality, and format that prospective experimental research can dictate from the start. In addition to these scientific limitations, because of its relational and often distant physical separation from the data subjects, and the sheer volume of the records involved, obtaining individual consent for the research can be difficult or impossible.

Advances in information-based medical research could also facilitate the movement toward personalized medicine, which will make health research more meaningful to individuals. In spite of the strides made in improving health through new treatments, it is widely known that most drugs are effective in only a fraction of patients who have the condition for which the drug is indicated. Moreover, a small percentage of patients are likely to have adverse reactions to drugs that are found to be safe for the majority of the population at the recommended dose.

Both of these phenomena are due to variability in the patient population. The surveys reviewed in this chapter focus on interventional clinical trials. A review of survey questions to gauge the public willingness to allow their medical records to be used in research can be found in Chapter 2. A number of studies suggest that most Americans have a positive view of medical research and believe that research is beneficial to society. A recent Harris poll found that nearly 80 percent of respondents were interested in health research findings, consistent with previous survey results Westin, A study in compiled data from 70 state surveys and 18 national surveys and found that the majority of Americans believe maintaining world leadership in health-related research is important.

Seventy-eight percent of respondents said that it is very important, and 17 percent said that it is somewhat important. Only 4 percent of Americans reported that maintaining world leadership in health-related research is not impor tant Woolley and Propst, Similar results were found in a survey—76 percent of respondents reported that science plays a very important role in our health, and 78 percent reported that science plays a very important role in our competitiveness Research! America, Little is known about the attitudes of individuals who have actually participated in medical research. However, the available evidence suggests that most research participants have positive experiences.

A recent Harris Poll found that 13 percent of respondents had participated in some form of health research, and 87 percent of those felt comfortable about their experience Westin, In a study focused on cancer, 93 percent of respondents who participated in research reported it as a very positive experience; 76 percent said they would recommend participation in a clinical trial to someone with cancer. Most physicians surveyed in this study stated that they believe clinical trial participants receive the best possible care, and have outcomes at least as good as patients receiving standard cancer treatment Comis et al.

Another study found that 55 percent of individuals who participated in a research study would be willing to participate again in a future research study Trauth et al. Public opinion surveys indicate that a majority of Americans are willing to participate in clinical research studies. In , a compilation of studies commissioned by Research! America found that 63 percent of Americans would be willing to participate in a clinical research study Woolley and Propst, This percentage has remained stable over time. A Research! America survey also found that 63 percent of Americans would be very likely to participate in a clinical research study if asked Research!

America, ; 68 percent of respondents reported that their desire to improve their own health or the health of others was a major factor in deciding whether to participate in a clinical research project Research! Other surveys also suggest that willingness to participate in research focused on specific diseases is quite high. In one survey, the percentage of respondents indicating a willingness to participate in a medical research study was 88 percent for cancer, 86 percent for heart disease, 83 percent for a noncurable fatal disease, 79 percent for addiction, 78 percent for depression, and 76 percent for schizophrenia Trauth et al. Respondents with greater knowledge of how research is conducted were more willing to participate Trauth et al.

Another study found that 8 of 10 Americans would consider participating in a clinical trial if faced with cancer. More than two-thirds of respondents said they would be willing to participate in a clinical trial designed to prevent cancer Comis et al. Americans also seem to be very supportive of medical research that relies on genetic data. The Trauth survey found that individuals with higher income levels, with a college or graduate degree, or with children were more likely to participate in research. Age affected willingness to participate: 57 percent of respondents ages 18—34 were willing to participate in research, but only 31 percent of respondents ages 65 or older were willing Trauth et al.

It is well documented that minorities participate in health research at a much lower percentage than white Americans. Many cultural, linguistic, and socioeconomic barriers could be responsible for this difference Giuliano et al. Several studies suggest that the low participation rates by racial and ethnic minority groups are due to their strong distrust of the medical research community compared to the general population Braunstein et al. Thus, it is likely that the low number of minority individuals participating in medical research is at least partly due to recruitment techniques that are ineffective for minority populations.

The survey that focused on cancer research suggests that one of the main reasons why individuals do not participate in research is lack of knowledge about the availability of clinical trials. In a survey of nearly 6, cancer patients, 85 percent said they were unaware of the opportunity to participate in a clinical trial. Respondents who did participate said they did so because of one of the following beliefs: 1 trials provide access to the best quality of care 76 percent , 2 their participation would benefit future cancer patients 72 percent , 3 they would receive newer and better treatment 63 percent , and 4 participation would get them more care and attention 40 percent Comis et al.

A recommendation from a physician can also impact participation. Twenty percent of respondents in an Italian public survey indicated that the presence of a physician as a reference during a research study influenced their willingness to participate Mosconi et al. In sum, surveys indicate that the vast majority of Americans have a positive view of medical research, believe that research is beneficial to society, and are interested in health research findings. Although little is known about the attitudes of individuals who have actually participated in medical research, the available evidence suggests that most research participants have positive experiences.

Surveys also suggest that a majority of Americans are willing to participate in clinical research studies. Notably, respondents with greater knowledge of how research is conducted were more willing to participate in research. The development of international codes, federal legislation, and federal regulation of human subjects often occurred in response to past abuses in biomedical experiments reviewed by Pritts, Box The most well-known examples included 1 reported abuses of concentration camp prisoners in Nazi experiments during World War II, and 2 the Tuskegee syphilis study begun in , in which researchers withheld effective treatment from affected African American men long after a cure for syphilis was found.

Most of the current principles and standards for conducting human subjects research were developed primarily to protect against the physical and mental harms that can result from these types of biomedical experiments. Therefore, they focus on the principles of autonomy and consent. Although the standards apply to research that uses identifiable health information, research based solely on information is not their primary focus. Nuremberg Code The Nuremberg Code, created by the international community after the Nazi War Crimes Trials, is generally seen as the first codification more In the United States, perhaps the most influential inquiry into the protection of human subjects in research was the Belmont Report.

The Belmont principles have been elaborated on in many settings, and served as the basis for formal regulation of human subjects research in the United States. In general, states do not directly regulate the activity of most researchers Burris et al. The committee agreed that uniformity of federal regulations on human subjects protection is desirable to eliminate unnecessary regulations and to promote increased understanding by institutions that conduct federally supported or regulated research.

As a result, in , other federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects of research, identical to Subpart A of 45 C. The Common Rule governs most federally funded research conducted on human beings and aims to ensure that the rights of human subjects are protected during the course of a research project. The Common Rule stresses the importance of individual autonomy and consent; requires independent review of research by an Institutional Review Board IRB ; and seeks to minimize physical and mental harm.

Privacy and confidentiality protections, although not defined in a detailed and prescriptive manner, are included as important components of risk in research. The framework for achieving the goal of protecting human subjects is based on two foundational requirements: the informed consent of the research participant and the review of proposed research by an IRB. This section describes some of the basic parameters of the Common Rule reviewed by Pritts, In general, the Common Rule applies only to research on human subjects that is supported by the federal government.

The Common Rule applies to most human subjects research conducted using federal funds, but its influence is broader because most institutions that accept federal funds sign an agreement a Federalwide Assurance or FWA with HHS to abide by the Common Rule requirements in all research, regardless of funding source. Nonetheless, some privately funded human subjects research is conducted outside the purview of federal regulation Goldman and Choy, ; Williams, Companies and other organizations may voluntarily choose to apply the Common Rule to their research projects, and many do.

However, research projects in which compliance is voluntary are not subject to oversight or disciplinary action by HHS Goldman and Choy, ; Williams, The Common Rule informed consent regulations focus primarily on the elements and documentation of informed consent rather than on the process used to obtain it. As to the process, the regulations require that informed consent be sought only under circumstances that provide the prospective subject with adequate opportunity to consider whether to participate.

The Common Rule also specifies a number of elements that must be provided when informed consent is sought. These elements include:. In certain limited circumstances, the Common Rule allows an informed consent to be for unspecified future research. For the most part, the required elements of an informed consent address all types of research, although some are more relevant to biomedical research e. One required element of informed consent is particularly relevant to research involving personally identifiable health information.

The Common Rule requires an informed consent to include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. Adopting the principles of the Belmont Report, the Common Rule requires that protocols for human subjects research be reviewed by an IRB Box before research may begin. The Common Rule specifies which level of IRB review is needed for various types of research and provides criteria for the IRB to consider during the review.

Although the Common Rule does not specify the procedures an IRB must follow in its review of protocols, it does require the IRB to have written procedures for how it will review protocols and document IRB decisions. Institutional Review Boards. The Common Rule requires that an IRB determine the following factors are satisfied to approve proposed research:. An IRB may waive the requirement to obtain informed consent or approve an alteration of the consent form for some minimal risk research. The IRB may also waive the requirement for signed consent in certain circumstances.

Data are considered personally identifiable if the identity of the subject is or may be readily ascertained by the investigator or associated with the information accessed by the researcher. Research involving only coded private information or specimens is not considered to involve human subjects under the Common Rule if the following conditions are met:. The Common Rule requirements for informed consent do not preempt any applicable federal, state, or local laws that require additional information to be disclosed to a subject in order for informed consent to be legally effective. Federal funding can be suspended or withdrawn from an institution when it is found to be in material violation of the Common Rule.

Neither does the Common Rule expressly provide a research participant with a private right of action. It should be noted, however, that recent cases indicate that courts may be willing to hold an institution liable under common law negligence theories where the approved informed consent form is determined to be less than adequate Shaul et al. Some health research is also subject to FDA regulations. The FDA is charged by statute with ensuring the protection of the rights, safety, and welfare of human subjects who participate in clinical investigations 25 involving articles subject to the Federal Food, Drug, and Cosmetic Act 26 the Act , as well as clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including drugs, medical devices, and biological products for human use Box In January , the FDA adopted regulations governing informed consent of human subjects 27 and regulations establishing standards for the composition, operation, and responsibilities of IRBs that review clinical investigations involving human subjects.

In addition, studies of efficacy based solely on medical records research are not permitted to support registration. Remaining differences in the rules are due to differences in the statutory scope or requirements Lee, The Common Rule and Privacy Rule make a somewhat artificial distinction between health research and some closely related health care practices, such as public health practice, quality improvement activities, program evaluations, 30 and utilization reviews, 31 all of which may involve collection and analysis of personally identifiable health information. It is important for IRBs and Privacy Boards to correctly distinguish among activities that are or are not subject to the various provisions of the Privacy Rule and the Common Rule. On the other hand, failure to correctly identify an activity as research could potentially allow improper disclosure of personally identifiable health information without sufficient oversight.

Thus, standard criteria are urgently needed for IRBs and Privacy Boards to use when making distinctions between health research and related activities, and the committee recommends that HHS consult with relevant stake holders to develop such standard criteria. Any criteria adopted by HHS should be regularly evaluated to ensure that they are helpful and producing the desired outcomes. The following sections describe some ongoing efforts to develop such criteria in the fields of public health and quality improvement. The intent of the committee is not to endorse these particular models, but rather to illustrate the challenges associated with making these distinctions and establishing standard criteria.

Neither the Common Rule nor the Privacy Rule provides a specific definition for public health research; rather public health research is included in the general definition of research. However, the Privacy Rule regulates public health practice differently from public health research see Chapter 4. The Centers for Disease Control and Prevention developed a similar method with an expanded assessment of intent.

For example, the model posits that in public health research, the intended benefits of the project extend beyond the study participants, and the data collected exceed the requirements for the care of the study participants. The model also assumes that public health practice is based on well-established medical interventions and is nonexperimental CDC, However, these models both have been criticized as too subjective and too dependent on the opinion of the person conducting the activity Gostin, ; Hodge, A new, more comprehensive model incorporating much of the previous two was recently proposed as a more objective checklist to be used by IRBs, Privacy Boards , and interested parties Hodge, ; Hodge and Gostin, The model is based on two primary assumptions.

First, the actor performing the activity in question is a governmental public health official, agent, agency, or entity at the federal, tribal, state, or local level. Second, the activity in question involves the acquisition, use, or disclosure of personally identifiable health data. The model is then divided into two stages. Stage 1 is applied to all activities, and can be used to distinguish practice from research in the easiest cases. Stage 1 Public health practice:. Quality improvement activities do not require IRB or Privacy Board approval under the Common Rule or the Privacy Rule, which classify quality improvement as a component of health care operations. However, in many cases, it is difficult for health care providers, IRBs, and Privacy Boards to determine whether a particular activity is purely for quality improvement, or whether it also entails research.

One survey 36 exploring opinions in the health care community about the need for IRBs to review various quality-related activities found that physicians conducting quality improvement were less likely than IRB chairs to believe that IRB review was required for a given hypothetical activity, or that informed consent was necessary Lindenauer et al. Recently, a highly publicized case has again brought the issue to the forefront for all the stakeholders Box Some members of the health care community have proposed requiring that all prospective quality improvement activities go through external review Bellin and Dubler, , while others have outlined specific criteria to differentiate quality improvement activities from research. For example, Casarett and colleagues developed a two-part test to identify quality improvement activities.

The principle of integrity is designed to ensure that data can be trusted to be accurate and that it has not been inappropriately modified. Availability is protecting the functionality of support systems and ensuring data is fully available at the point in time or period requirements when it is needed by its users. The objective of availability is to ensure that data is available to be used when it is needed to make decisions. Effectively executing all three tenets of the Security Triad creates an ideal outcome from an information security perspective.

Consider this example: An organization obtains or creates a piece of sensitive data that will be used in the course of its business operations. Because the data is sensitive, that data should only be able to be seen by the people in the organization that need to see it in order to do their jobs. It should be protected from access by unauthorized individuals. This is an example of the principle of confidentiality. When the individual that needs that piece of data to perform a job duty is ready to utilize it, it must be readily accessible i. This describes the principle of availability. And finally, the data will be used in calculations that affect business decisions and investments that will be made by the organization.

Therefore, the accuracy of the data is critical to ensure the proper calculations and results upon which decisions will be made. The assurance that the data has not been improperly tampered with and therefore can be trusted when making the calculations and resulting decisions is the principle of integrity. This makes way for the firms to analyze, examine and execute administration in a manner that is most likely to achieve the set aims. As such, strategizing or planning must be covered as the deciding administration factor.

Strategic Management and the role it plays in the accomplishments of firms has been a subject of thorough research and study for an extensive period of time now. Strategic Management in an organization ensures that goals are set, primary issues are outlined, time and resources are pivoted, functioning is consolidated, internal environment is set towards achieving the objectives, consequences and results are concurred upon, and the organization remains flexible towards any external changes. As more and more organizations have started to realize that strategic planning is the fundamental aspect in successfully assisting them through any sudden contingencies, either internally or externally, they have started to absorb strategy management starting from the most basic administration levels.

In actuality, strategy management is the essence of an absolute administration plan. For large organizations, with a complex organizational structure and extreme regimentation, strategizing is embedded at every tier. Apart from faster and effective decision making, pursuing opportunities and directing work, strategic management assists with cutting back costs, employee motivation and gratification, counteracting threats or better, converting these threats into opportunities, predicting probable market trends, and improving overall performance.

Keeping in mind the long-term benefits to organizations, strategic planning drives them to focus on the internal environment, through encouraging and setting challenges for employees, helping them achieve personal as well as organizational objectives. At the same time, it is also ensured that external challenges are taken care of, adverse situations are tackled and threats are analyzed to turn them into probable opportunities. We have a thirst to learn new subjects and curate diverse pieces for our readers.

The ethics of using Characteristics Of The Human Respiratory System methods To Kill A Mockingbird Social Class Essay improve health care quality and safety. The investigator Cunningham Scene In To Kill A Mockingbird cannot readily ascertain the identify of the Cunningham Scene In To Kill A Mockingbird s to whom the coded private information or specimens Cunningham Scene In To Kill A Mockingbird because, for example:. These groups help researchers to recruit research participants by using the Characteristics Of The Human Respiratory System of the community to understand health problems and to design activities that the community is Obsession In Willy Lomans Death Of A Salesman to value. The Fellowship Of The Ring Analysis funding can be suspended or withdrawn from an institution when it is found to be in material violation of the Common Rule. When the individual that needs that piece of data to perform a job duty is ready to utilize it, Characteristics Of The Human Respiratory System must be readily Russian Revolution Causes i. Research involving only coded private information or Cunningham Scene In To Kill A Mockingbird is not considered to involve human subjects under the Common Rule if The Fellowship Of The Ring Analysis following Characteristics Of The Human Respiratory System are met:.