Nursing Informatics Regulations

Regulations have been established to address the nursing informatics world in an effort to improve security, safety, and quality of patient care and records. Regulatory government bodies have initiated policies to ease the implementation of electronic health records (EHRs).

They also regulate the electronic health systems to protect the rights of providers and patients. Patients have the right to privacy and they have the right to choose how to share their information with other healthcare providers.

It is vital to be cognizant of the following state and federal laws to ensure that protected health information (PHI) stays secure when stored and transmitted by EHRs.

1. Privacy Act of 1974

The Privacy Act of 1974 establishes a code of fair information practices that oversee the collection, use, maintenance, dissemination of information about people that is maintained in systems of records by federal agencies.

The law permits American citizens to know about the information collected about them, declare the authenticity of the data, and acquire copies of the information. The Indian Health Services and the Veterans Health Administration are subject to these regulations.


The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) wrote information management (IM) standards in the mid-1990s.

The JCAHO has had changing capacities to regulate and determine regulations related to patient care, several of which are focused on PHI confidentiality. These regulations have been reviewed to accommodate the increasing adoption of EHRs systems.


I. The Health Insurance Portability and Accountability Act (or HIPAA)

HIPAA was enacted in 1996 to allow for continued insurance coverage even after job loss or changes. HIPPA also included a segment on healthcare technology as patients are allowed to access their electronic health records.

Confidentiality is a represents a significant part of HIPAA as it addresses the safer and proper handling of patients’ records. Standards were established to allow for identification of health insurance plans, providers, employers including the National Provider Identifier Standard (NPIS) that gives every physician a unique number to use in all healthcare segments.

II. Health Information Technology for Economic and Clinical Health (HITECH)

The HITECH was enacted in 2009 to establish a national healthcare infrastructure. The HITECH aimed to govern the promotion of health information technology (IT) including security, safety, and quality as well as the secure exchange of information. This legislation has various provisions including:

  • Superior HIPAA enactment with austere amenability and large penalties for confidentiality breaches. 
  • Expansion of health information technology (HIT).
  • Interoperability (the exchange of patient data via safe networks connecting numerous healthcare organizations and providers).
  • Report of health record breaches.
  • Inducements to those who maintain accountability when implementing healthcare technology.
  • Standards for certifying electronic health record programs in each healthcare organization.

4. Affordable Care Act (ACA)

The ACA was enacted in 2010 to transform the healthcare insurance landscape in the United States. Some of the ACA goals included reducing the costs of healthcare and making coverage accessible to individuals who were not insured.

Apart from the insurance coverage provision, ACA also included provisions on healthcare technology. The ACA supports workplace training programs focusing on healthcare informatics.

Among the key priorities of this legislation is ensuring precise collection of data, quantifying the work delivered to the patient, and monitoring the care outcomes.

Furthermore, the legislation promotes interoperability programs in healthcare to allow providers to access electronic health records, exchange patients’ information, and communicate with other providers. 

5. The Food and Drug Administration Safety and Innovation Act (FDASIA) 

The FDASIA was ratified in 2012 as a result of a collaboration between the Food Drug Administration (FDA) and the U.S. Department of Health and Human Services(HHS).

The aim was to develop a regulatory framework for HIT to enhance mobile applications and other approaches to encourage patient safety and innovation in the delivery of healthcare.

The FDASIA recommends that software used in the facility should be reliable, support safety, and improve quality. It must also include acknowledged best-practices or standards for care, testing function of technical devices and produced used in healthcare for safety and quality.


The Medicare Access & CHIP (Children’s Health Insurance Program) Reauthorization Act (MACRA) was ratified in 2015 to ensure that healthcare is improved, Medicare Part B costs are regulated, and physicians receive fair remuneration.

MACRA encouraged the adoption of a value-based reimbursement model whereby providers are paid based on the effectiveness, value, efficiency, and quality of the medical care delivered.

MACRA also included combining the current quality reporting program into a single system. This legislation encourages optimization of electronic health record system to improve data handling and storage.

7. 21st Century Cures Act

The 21st Century Cures Act  was ratified in 2016 with different aims covering various aspects of healthcare including advancing and individualizing health care, streamlining the system, supporting research, and encouraging further innovation.

The legislation aimed to help enhance handling data regulation at both macro and micro-levels. The 21st Century Cures Act is keen on configuring EHRs in that their users are entices to share information to the highest possible level.

At macro-level, the legislation focuses on developing the national information network (NHIN). Furthermore, with the development of the Trusted Exchange Network, data accessibility will be enhanced. 

Cures Act also help mitigate the interoperability barriers in healthcare to support seamless flow of information in the care continuum.

Overall, regulations are an important part of nursing informatics. Nurse should have an overall understanding of the regulations that govern their efficient, effective, and safe use of health information technology. 

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