Regulatory Groups Role in Health IT Selection

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Table of Contents

Introduction
Interoperability
Usability
Safety
Implementation of New Digital Innovation Plan
Conclusion
References

Introduction

A health information technology system is defined as a scheme designed to help manage medical data. Laws have been enacted, such as the Patient Protection and Affordable care Act (ACA) 2010, that avail tenets for expanding access to medical technology for both consumers and care providers (Ong et al., 2018). The ACA was enacted when the mobile device industries, app development, and health software were experiencing tremendous growth. Consequently, this brought the stakeholders involvement in selecting health IT systems (HIT) to perform different roles (Eisenberg & Price, 2017). Therefore, there is a need to understand the roles, goals, and interests of the Regulatory groups or boards in this process.

Every government has regulatory boards that address the health informatics world to improve patient care and records quality, security, and safety. The FDA was the first regulatory body to control the selection of healthcare technologies in 1976 (Eisenberg & Price, 2017). The law required FDA approval to choose and use any machine, implement, apparatus, instrument, vitro reagent, implants, contrivance or other alike or associated article and any component, accessory part by consumers (Ong et al., 2018). During the time, the leading health technology comprised things such as cochlear implants and contact lenses only.

Interoperability

Regulatory bodies are responsible for facilitating information sharing and interoperability, which is a critical role alongside other technological outcomes of advancing a more cost-effective, high-quality, and patient-centered care (Ong et al., 2018). Interoperability can be interpreted as a secure platform that provides exchange and utilization of electronic health data without applying end-users special efforts. It can also mean that there is no information blocking for any stakeholders who want to access and use such systems.

Usability

Usability is a terminology that describes how different specialized groups can apply health IT products to meet specific objectives efficiently and effectively. Besides, they facilitate care providers to select a technology that reflects evidence-based, human factor science, user-centered design principles, and best practices (Ong et al., 2018). Such that it does not create unnecessary liability to end-users. Their role is to ensure such technology meets cultural competency that can enable access by consumers with different dialects and abilities.

Safety

Regulatory boards have a role and interest in ensuring the selected health systems meet specific patient safety objectives. This covers three important domains: a secure system, safe utilization of health IT, and finally, using health IT to better patient safety. The government mandates the FDA to regulate higher risk digital health and health IT (Eisenberg & Price, 2017). Additionally, other federal groups such as the ONC and AHRQ have coordinated efforts to address health IT safety, which lies within the private sector and is not covered by the FDA (Ong et al., 2018). They mainly focus on process certification, standards, coordination, and transparency.

Implementation of New Digital Innovation Plan

In response to high technological demands, regulatory bodies such as the FDA are responsible for implementing a new digital innovation plan, from product-based to developer-based. This approach will enable them to offer private third-party developers certification to advance quality products and processes (Ciani et al., 2017). They encourage the selection of health IT systems by improving the development and utilization of health IT regulatory reforms.

This is achieved by convening workshops and forming workgroups consisting of expert stakeholders from organizations representing healthcare systems, consumers and patients, hospitals, technology companies, and clinicians (Ciani et al., 2017). They examine the present regulator landscape, establish the most pressing need for technology use, and produce the agreed recommendation for applying various technologies.

Conclusion

Conclusively, it is the role of every regulatory body in government to address healthcare informatics. In that way, there will be a smooth running and quality administration of service to patients. Regulators ensure the proper selection of health information technologies that facilitate and archive data for healthcare growth. They need to promote healthcare technologies that respond by meeting the demands of health providers, staff, and consumers at all times.

References

Ciani, O., Wilcher, B., van Giessen, A., & Taylor, R. S. (2017). Linking the regulatory and reimbursement processes for medical devices: the need for integrated assessments. Health economics, 26, 13-29.

Eisenberg, R. S., & Price, W. N. (2017). Promoting healthcare innovation on the demand side. Journal of Law and the Biosciences, 4(1), 3-49.

Ong, J., Parchment, V., & Zheng, X. (2018). Effective regulation of digital health technologies. Journal of the Royal Society of Medicine, 111(12), 439-443.

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