The Food and Drug Administration and Health IT

Introduction

A conflict of interest arises when an individual’s welfare, such as social factors, finances, family, or friendships, weakens their judgment, actions or decisions, at work. Conflicts of interest are taken very seriously by government agencies, and they are strictly controlled. This paper aims to discuss the issue of conflict of interest, including the Food and Drug Administration (FDA), and how it affects the organization. This paper will also discuss and differentiate between electronic health records (HER) and electronic medical records (EMR) and how they are interdependent.

In the United States, the Food and Drug Administration (FDA) regulates $2.5 trillion in medicines, medical strategies, and other consumer goods. Millions of Americans rely on the FDA to approve new medications, devices, and biologics that hit the market every year (Hayes and Prasad, 2018). The FDA routinely consults Advisory Committees (ACs) for professional technical, policy, and scientific input during the policymaking process, and the FDA generally follows the ACs’ recommendations. Industries that are controlled, such as drug and device manufacturers, frequently demand experts who can provide competent guidance to the federal government. Despite the apparent need to resolve any conflicts of interest among AC members, stakeholders are increasingly agreeing that replacing existing levels of AC competence with non-conflicted sheets would be exceedingly difficult, if not impossible.

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Furthermore, a conflict of interest may probably affect information from the organization; to determine if a conflict exists, FDA examines any financial interests related to the meeting’s topic. There may not be a conflict of interest if the financial interest is unrelated to the meeting topics (Hayes and Prasad, 2018). FDA evaluates whether the meeting’s outcomes or conversation will have a predictable and direct influence on the individual’s interests to be considered a financial conflict of interest.

Electronic medical records (EMRs) are computerized paper charts utilized in doctor’s offices, hospitals, and clinics. EMRs are electric medical records that store information and notes obtained by and for doctors in a particular hospital, clinic, or office. EMRs are better than paper records because they allow doctors to keep track of information over time, choose people for preventative tests and screenings, increase the value of health care, and keep track of patients (Anshari, 2019). According to Anshari (2019), electronic health records (EHRs) are intended to provide a more comprehensive picture of a patient’s treatment than the traditional clinical info collected in a doctor’s office. EHRs hold data from all physicians involved in a patient’s care, and any authorized clinician with access to the information can treat that patient.

Hospital Information Systems (HIS)

The Hospital Information System (HIS) is an inclusive statistic structure that meets the needs of hospitals for daily activities such as patient and planning care. In other terms, a hospital information system (HIS) can also be clarified as a scheme that can provide all aspects of hospital operations, including financial, administrative, and clinical (Moghaddasi et al., 2018). Using a hospital information system offers doctors’ appointments plans, which provides a central repository of data about a patient’s medical past.

Laboratory Information Systems (LIS)

A laboratory information structure is a type of information control system specifically developed to automate laboratory procedures. It often connects personal computers (PCs) to laboratory analytical equipment (Lukić, 2017). By monitoring and reporting crucial data about patient care, immunology, infection, and treatment status, the standard LIS has aided the operations of public health organizations. These health institutes include clinics and hospitals, as well as their related labs.

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Nationwide Health Information Network (NHIN)

The Nationwide Health Information Network (NHIN) is a strategy developed by the Office of the National Coordinator for Health Information Technology (ONC) in 2004 with the goal of enhancing efficiency and healthcare quality by establishing a nationwide health information sharing system (Ruley et al., 2018). The National Health Information Network (NHIN) is a set of standards that govern the protected exchange of health data for useful purposes.

Nursing Information Systems (NIS)

The Nursing Information System (NIS) is a section of a healthcare statistics system that deals with nursing matters, especially nursing record management. As a result, the nursing information system enhances proper operation clinical data integrity while also meeting user requirements. This system makes healthcare information more accessible, nursing records more readable, the recording process less repetitive, workflow better supported, and legal norms and principles are more respected.

Picture Archiving and Communication Systems (PACS)

Picture Archiving and Communication System (PACS) is a therapeutic medicinal imaging technology that allows cost-effective medical image storage, retrieval, dissemination, and administration. PACS allows for the digital transmission of electronic pictures and reports. As a result, manual film jacket filing and distribution are no longer necessary since PACS enables healthcare institutes and companies to store and view all forms of medical imaging internally and externally.

Pharmacy Information Systems (PIS)

The Pharmacy Information System (PIS) is a hospital data system that efficiently implements a variety of pharmaceutical care models planned around critical care services. PIS, in general, aids pharmacists in the management of medication use, scientific knowledge of therapies, medication services, and financial management. The PIS can function as a hospital information system (HIS) built when used with the Computerized Physician Order Entry (CPOE) system.

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Radiology Information Systems (RIS)

The Radiological Information System (RIS) is a technology solution for completely modernizing and computerizing radiology center operations and converting electronic administration, digital recordings, and film to paper. The RIS system establishes an advanced radiology center where data is always accessible at the appropriate time and in the correct location. Security and confidentiality of data must be prioritized in RIS, similar to any other information system.

Conclusion

According to the preamble, the FDA is capable of adequately safeguarding consumers from unreasonably harmful medications. Nonetheless, the researchers’ competing interests have harmed the objectivity and quality of the evidence used by the FDA to make its conclusions. The FDA lacks the resources to assess these competing interests and safeguard the public from excessively harmful medications. Similarly, the FDA cannot objectively monitor all medications due to its competing interests.

References

Anshari, M. (2019). Redefining electronic health records (EHR) and electronic medical records (EMR) to promote patient empowerment. IJID (International Journal on Informatics for Development), 8(1), 35. Web.

Hayes, M. J., & Prasad, V. (2018). Financial conflicts of interest at FDA drug advisory committee meetings. Hastings Center Report, 48(2), 10-13. Web.

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Lukić, V. (2017). Laboratory information system – Where are we today? Journal of Medical Biochemistry, 36(3), 220-224. Web.

Moghaddasi, H., Mohammadpour, A., Bouraghi, H., Azizi, A., & Mazaherilaghab, H. (2018). Hospital information systems: The status and approaches in selected countries of the Middle East. Electronic physician, 10(5), 6829-6835. Web.

Ruley, N., Walker, V., Studeny, J., & Coustasse, A. (2018). The nationwide health information network: The case of the expansion of health information exchanges in the United States. The Health Care Manager, 37(4), 333-338.

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