Most health care providers must follow the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (Privacy Rule), a federal privacy law that sets a baseline of protection for certain individually identifiable health information (“health information”).
The Privacy Rule generally permits, but does not require, covered health care providers to give patients the choice as to whether their health information may be disclosed to others for certain key purposes. These key purposes include treatment, payment, and health care operations.
While it is not required, health care providers may decide to offer patients a choice as to whether their health information may be exchanged electronically, either directly or through a Health Information Exchange Organization (HIE). That is, they may offer an “opt-in” or “opt-out” policy [PDF - 713 KB] or a combination.
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The U.S. Department of Health and Human Services (HHS) does not set out specific steps or requirements for obtaining a patient’s choice whether to participate in eHIE. However, adequately informing patients of these new models for exchange and giving them the choice whether to participate is one means of ensuring that patients trust these systems. Providers are therefore encouraged to enable patients to make a “meaningful” consent choice rather than an uninformed one.
You can read more about patient choice and eHIE in guidance released by the Office for Civil Rights (OCR): The HIPAA Privacy Rule and Electronic Health Information Exchange in a Networked Environment [PDF - 164KB].
Yes. There are some federal and state privacy laws (e.g., 42 CFR Part 2, Title 10) that require health care providers to obtain patients’ written consent before they disclose their health information to other people and organizations, even for treatment. Many of these privacy laws protect information that is related to health conditions considered “sensitive” by most people.
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HIPAA created a baseline of privacy protection. It overrides (or “preempts”) other privacy laws that are less protective. But HIPAA leaves in effect other laws that are more privacy-protective. Under this legal framework, health care providers and other implementers must continue to follow other applicable federal and state laws that require obtaining patients’ consent before disclosing their health information.
The resources listed below provide links to some federal, state, and organization resources that may be of interest for those setting up eHIE policies in consultation with legal counsel. Implementers may also want to visit their state’s law and policy sites for additional information.
Encourage providers, HIEs, and other health IT implementers to seek expert advice when evaluating these resources, as privacy laws and policies continually evolve. The resources are not intended to serve as legal advice or offer recommendations based on an implementer’s specific circumstances.There are several laws designed to protect Americans’ personal health information. Patients have the right to privacy, and they have the right to have the information shared with healthcare providers who will use it with discretion in the patient’s best interest. If you have or are considering a career in health informatics, it is important to be aware of federal and state laws so that Protected Health Information (PHI) remains secure when stored and transmitted by electronic health record systems.
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The Privacy Act of 1974 regulates information collected by the federal government and its agencies. The legislation allows citizens to know what information is collected about them, assure the veracity of that data and obtain copies of the information. The Veterans Health Administration and Indian Health Services are subject to these regulations.
The Confidentiality of Alcohol and Drug Abuse Patient Records rule allows for additional privacy in any federally-assisted drug or alcohol abuse program. Identity, diagnosis, and treatment are treated as confidential information. Patient impairment does not excuse the release of confidential patient information.
The Conditions for Coverage of Specialized Services by Suppliers is part of Medicare laws that govern providers and require that all PHI be kept confidential and protected against loss, destruction, or unauthorized use.
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This information requires the written approval of the patient before it is used or forwarded. Hospitals must protect this information against unauthorized use and current Electronic Health Records allow for monitoring and securing data.
Patients always have a right to access their records; an institution is allowed to charge a usual and customary fee for paper copy costs. These laws extend to home health agencies and long-term care facilities.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is a private organization that has been used since 1965 to accredit hospitals and facilities, which allowed for their participation in Medicare.
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In 2010, the process changed to provide for review by Centers for Medicare and Medicaid Services (CMS) prior to facility participation. JCAHO has had varying abilities to control and determine rules related to patient care, several of which pertain to PHI confidentiality. These rules are constantly under review and have included a large number of recent revisions coinciding with the increasing prevalence of EHRs.
The Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009 empowers the Federal Department of Health and Human Services (HHS) to oversee the promotion of Health IT – including quality, safety and security as well as the secure information exchange.
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was enacted to allow for the continuance of health insurance coverage in situations involving job changes or loss. Major provisions of this law were enacted to formulate and regulate federal guidelines and standards pertaining to electronic healthcare. Standards were developed to allow for identifications of providers, health insurance plans, and employers, including the National Provider Identifier Standard (NPIS), which provides every physician with a unique number used in all aspects of healthcare.
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The Affordable Care Act of 2010 was set up to fundamentally change the way people are insured; goals include lowering healthcare costs and making coverage accessible to previously uninsured people. The law is undergoing major changes as issues with its implementation are encountered. Final resolutions should be expected in the coming years as interpretations of its standards are developed and enacted. As revisions are implemented, there may be many changes to the way healthcare is delivered, including control of PHI.
The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 resulted in the collaboration of the HHS and FDA to recommend a regulatory framework for Health IT to improve mobile applications and other means to promote patient safety and innovation in healthcare delivery.
Many federal and state regulations affect the health informatics field. Because the measures were developed in isolation at different times, there is some conflicting legislation with regard to patient care and the collection and maintenance of patient records. Familiarity with these laws and their implications is paramount for improved functioning in the promotion and development of computer-based patient-care systems.
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The Medicare Access & CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015 is intended to ensure that physicians are paid fairly, that Medicare Part B costs are controlled, and that healthcare is improved.
The passage of MACRA in August 2015 signaled a move away from the Sustainable Growth Rate (SGR) Formula once used to determine physician reimbursement and toward a model based on the quality, efficiency, value, and effectiveness of the medical care provided. In addition, MACRA also will combine existing quality reporting programs into one new system.
The 21st Century Cures Act, passed by both houses of Congress and signed into law by President Obama in December 2016, covers many facets of healthcare. The goals for all, though, are the same: to “help modernize and personalize health care, encourage greater innovation, support research, and streamline the system, ” according to the act’s mission statement.
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Among the ways those goals will be sought is by the discovery of cures in basic science; streamlining the drug and device development process; unleashing the power of digital medicine and social media at the treatment delivery phase.Maya has worked in the clinical, education, and management sections of healthcare for over 25 years and holds bachelor's degree in Speech and associate degree in Nursing.
As the implementation of healthcare informatics increases, organizations and providers must ensure they meet the relevant regulatory requirements. Review the meaning of healthcare informatics and the major legislation that regulates it, from HIPAA and HITECH to the ACA and FDASIA. Updated: 01/13/2022
Sara, a registered nurse, is a leader in her unit for compliance with regulations. She has trained in healthcare informatics and remains vigilant by providing education for others on the role of security breach prevention. Sara is considering a nursing informatics position where she'll design workflow for clinical staff to begin using electronic patient health records as well.
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I would definitely recommend to my colleagues. It’s like a teacher waved a magic wand and did the work for me. I feel like it’s a lifeline.
Legislation was passed in 1996 to allow insurance coverage to continue in case of job loss or changes. Parts of this law are specific to healthcare technology as patients can now have access to their electronic health records. Confidentiality is a large part of this law as it addresses
