Electronic Health Records to Facilitate Clinical Research

The management of food and drugs represents a complicated issue that requires rigid guidelines and well-established standards. In the United States, the Food and Drug Administration (FDA) defines the policies toward food and drug management, including the approval of drugs and the identification of food-related threats to the American population. FDA policies have experienced several major changes since the recent technological breakthrough. Most of these alterations to the existing set of guidelines regarding the management of food, drugs, and the relevant resources are linked directly to the use of innovative technologies that allow for massive improvements in data management. The recent change in the FDA policy is no exception to the identified trend since it demands that electronic health records (EHR) should be used when conducting food- and drugs-related clinical investigations (Caccomo, 2018).

However, the policy also raises several questions that need to be addressed before transferring to the identified mode of operating. Therefore, the specified step implies that healthcare organizations will be invited to maintain control over the HER management process. The identified change suggests a significant reduction in the degree of agency for the FDA, yet it also implies the active promotion of interdisciplinary cooperation between the company’s employees and healthcare staff from local hospitals. Therefore, to ensure that the focus on using EHR should not impede the work of nurses and healthcare experts, one must keep the focus of the process consistent and ensure the correct use and functioning of available communication tools.

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The issue of using patient data in clinical investigations conducted by the FDA has been in existence for a significant amount of time. Performing investigations regarding specific incidents such as food poisoning are crucial to maintaining the quality of food and drugs at the required high level. Thus, the lack of a uniform approach toward handling the issues associated with health-related concerns defined the necessity to design a uniform approach with the focus on managing patients’ health data.

The policy mentioned above is supposed to assist in managing investigations associated with the mismanagement of food and drugs on an organizational level. The use of patients’ personal data is crucial to the successful identification of the victims, the vulnerable population, in general, the impact of the concern, and the factors that may have contributed to its development (Caccomo, 2018). As a result, one may design a comprehensive strategy for handling the current issue and preventing similar instances in the future.

The policy represents a positive shift in the relationships between FDA and nursing organizations, as well as offers the premises for improving patient outcomes fast. Specifically, the new guidelines place a very powerful emphasis on cooperation between FDA and nursing organizations. The interdisciplinary cooperation that the identified communication entails will lead to the identification of a vast range of factors that present a threat to vulnerable populations. In addition, the enhanced communication will cause communication that is more efficient and, thus, more timely management of emergent issues (Caccomo, 2018). As a result, food- and drug-related issues, should they occur, will not take the scale of an epidemic. Instead, the effects of a possible health issue will be localized and diminished greatly, with the further rapid solution of the concern.

Nevertheless, there are some minor issues that may impede the process of improving the quality of healthcare and the delivery of respective services. For example, conflicts may occur in case the actions of the FDA and local healthcare organizations are not coordinated well. Moreover, the transfer of patients’ personal data to a third party, which the FDA represents in this case, may cause conflicts. Particularly, the use of patients’ data requires the certification of the Office of the National Coordinator for Health Information Technology (ONC), which the FDA may fail to obtain. Therefore, numerous foreseeable problems with information management can be deemed as the evident weakness of the policy newly designed by the FDA (Cowie et al., 2017). As a result, patients as the key stakeholders will be affected negatively by the policy. Similarly, nursing organizations will also suffer from the disruption of their internal processes associated with health management.


At present, there are no alternative policies that allow coordinating the actions of the FDA and local healthcare organizations. Therefore, there is a strong need to introduce the tools that could help the specified entities coordinate their actions to reduce threats to people’s health. Although the use of EHR is inevitable in the identified scenario, the process of securing the data and confirming its further transfer can be simplified to a considerable extent, thus, reducing the threat of data loss and a drop in the quality of care. Particularly, the guidelines provided by the ONC can be simplified and taught to staff members, including both FDA and local healthcare facilities, to ensure that the process of data transfer takes as little time as possible.

Moreover, it should be borne in mind that the extended definition of patient data as it is explained by ONC includes not only EHR but also the use of all forms of health IT (U.S. Department of Health and Human Services, 2018). For instance, nurses may have to incorporate the information received from monitoring devices and other medical appliances, as well as sensors, technologies used to provide assistive services, and similar tools (Miotto, Li, Kidd, & Dudley, 2016). Consequently, embracing every possible source of information in an attempt to construct a full patient profile and determine key factors affecting their state does not seem possible. To resolve the specified problem, one will need to establish a set of rigid standards for IT data collection. As a result, only sources with relevant information will be considered. At the same time, FDA must be provided with an opportunity to use unclassified information sources on a case-by-case basis to address complex situations.

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The potential impact of the specified strategies is rather impressive. Complete patient profiles can be constructed based on the data provided by local healthcare facilities. The information in question will provide the foundation for massive epidemiology studies regarding the impact of specific food and drugs on selected types of population (Slight et al., 2015). Consequently, health outcomes will improve once research results inform the design of new health management approaches.

The trade-offs between the alternatives are minor, yet they may have a tangible impact on people’s health. Particularly, the failure to capture crucial patient data, be it due to restrictions to personal information or because of the absence of clear guidelines, will have a detrimental effect on people’s health. Therefore, the available opportunities may need to be combined to produce a compromise that will meet the needs of all stakeholders involved.


As the overview of the alternatives provided above shows, it is desirable to introduce a compromise between the current policy of data management and a more reliable framework for arranging patients’ information. The guidelines provided by ONC need to be simplified for nurses to learn and implement successfully. As a result, full compliance with the existing standards will be achieved. In addition, patients may need to take an active part in handling their personal data. Particularly, consultations will have to be provided to vulnerable populations to guarantee complete non-disclosure of their personal data. Finally, a shift in the corporate philosophy of FDA and nursing organizations toward cooperation and compliance with essential ethical principles will need to be viewed as necessary. Thus, the stances of data mismanagement or leakage will be prevented.

There may be certain barriers to the implementation of the strategy. Specifically, impediments toward data transfer will have to be considered closely. Technical issues, as well as the scenarios in which cross-cultural miscommunication occurs, must be avoided at all costs. The focus on diversity and multicultural communication as precaution measures will have to be deployed. In addition, technology must be updated on regular basis to ensure safety from cyberattacks.


The analysis conducted above shows that the current framework for obtaining, processing, storing, and transferring patient data from local nursing and healthcare organizations to FDA could use major improvements. The significance of the policy cannot be doubted since the cooperation between FDA, and local nursing facilities will help prevent a range of instances associated with the use of specific medications. In addition, legal issues such as the prescription of off-counter drugs will be addressed once nursing facilities start collaborating with FDA (Sittig et al., 2015). Moreover, the identified concern may finally be resolved through collaborative research implemented by FDA and local nursing facilities. Thus, the issue needs to be managed on the level of healthcare systems. By exploring the problem within the framework of a system, one will be capable of locating the existing relationships within it and determine the factors that define the management of patients’ EHR. As a result, the scenarios involving personal data leakage will be avoided.


A recent policy issued by the FDA indicating that the organization will need to use patients’ HER for better management of health issues is not devoid of controversies. Because of the possibility of data leakage, the suggested approach may affect a vast range of patients negatively. However, the benefits that the identified policy incorporates are also quite numerous and very important for the further improvement of healthcare service quality. The emphasis on the interdisciplinary cooperation between FDA and nursing organizations deserves particularly close attention as a crucial opportunity. Thus, the existing policy should be changed toward a more patient- and security-oriented approach with an improved data management framework. Thus, nurses will be able to deliver services of better quality, whereas FDA will be capable of addressing some of the current concerns, such as off-the-counter drug prescription. Moreover, the enhancement of research, which the collaboration between FDA and nursing organizations may entail, is bound to have a vastly positive effect on the quality of care, in general, and management of some of the contemporary health concerns, in particular. Improved interventions and treatment strategies will make the process of recovery faster and significantly easier. Thus, the future analysis of the policy in question will require a discussion of problems such as off-the-counter medicine prescription and the slow pace of research at the FDA.


Caccomo, S. (2018). FDA issues a policy to facilitate the use of electronic health record data in clinical investigations. Web.

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Cowie, M. R., Blomster, J. I., Curtis, L. H., Duclaux, S., Ford, I., Fritz, F.,… Michel, A. (2017). Electronic health records to facilitate clinical research. Clinical Research in Cardiology, 106(1), 1-9.

Miotto, R., Li, L., Kidd, B. A., & Dudley, J. T. (2016). Deep patient: an unsupervised representation to predict the future of patients from the electronic health records. Scientific Reports, 6(26094), 1-10.

Sittig, D. F., Murphy, D. R., Smith, M. W., Russo, E., Wright, A., & Singh, H. (2015). Graphical display of diagnostic test results in electronic health records: A comparison of 8 systems. Journal of the American Medical Informatics Association, 22(4), 900-904.

Slight, S. P., Berner, E. S., Galanter, W., Huff, S., Lambert, B. L., Lannon, C.,… Payne, T. H. (2015). Meaningful use of electronic health records: experiences from the field and future opportunities. JMIR Medical Informatics, 3(3), 1-7.

U.S. Department of Health and Human Services. (2018). Use of electronic health record data in clinical investigations guidance for industry. Web.

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