
Complying With HIPAA: A Checklist for Covered Entities
- 1. Assign HIPAA responsibility. ...
- 2. Know the use and disclosure rules. ...
- 3. Know individuals’ rights. ...
- 4. Implement and maintain written policies. ...
- 5. Develop compliant forms. ...
- 6. Execute appropriate business associate agreements. ...
- 7. Perform and document a risk analysis. ...
- 8. Implement required safeguards. ...
What is defined as covered entity under HIPAA?
Initially, the definition of HIPAA covered entity seems clear-cut. A HIPAA-covered entity is defined by the Privacy Rule as any healthcare provider, health plan, or healthcare clearinghouse, that communicates Protected Health Information (or PHI) in digital format. Looking deeper into that definition reveals some gray areas.
Who and what are covered under HIPAA?
Covered entities include health plans, medical providers, and healthcare clearinghouses (entities that transmit protected health information into or out of standard formats). Information in education records or employment records is not protected under HIPAA, and neither is information about a person who died more than 50 years ago.
Which entities should comply with the HIPAA rule?
To comply with the HIPAA Security Rule, all covered entities must do the following: Ensure the confidentiality, integrity, and availability of all electronic protected health information Covered entities should rely on professional ethics and best judgment when considering requests for these permissive uses and disclosures.
Is a pharmacy a covered entity under HIPAA?
Yes, HIPAA does apply to pharmacies. HIPAA, or the Health Insurance Portability and Accountability Act of 1996, aims to protect the privacy of personal health information (PHI) and prevent the disclosure of PHI to unqualified entities.

What are the three covered entities that must comply with HIPAA?
Covered entities are defined in the HIPAA rules as (1) health plans, (2) health care clearinghouses, and (3) health care providers who electronically transmit any health information in connection with transactions for which HHS has adopted standards.
What are five covered entities under HIPAA?
Covered entities under HIPAA include health plans, healthcare providers, and healthcare clearinghouses. Health plans include health insurance companies, health maintenance organizations, government programs that pay for healthcare (Medicare for example), and military and veterans' health programs.
Which of the following must a covered entity or business associate do before sharing PHI?
Before having access to PHI, the Business Associate must sign a Business Associate Agreement with the Covered Entity stating what PHI they can access, how it is to be used, and that it will be returned or destroyed once the task it is needed for is completed.
What is a covered entity obligated to do?
Individuals, organizations, and agencies that meet the definition of a covered entity under HIPAA must comply with the Rules' requirements to protect the privacy and security of health information and must provide individuals with certain rights with respect to their health information.
What are the 4 main rules of HIPAA?
The HIPAA Security Rule Standards and Implementation Specifications has four major sections, created to identify relevant security safeguards that help achieve compliance: 1) Physical; 2) Administrative; 3) Technical, and 4) Policies, Procedures, and Documentation Requirements.
Which of the following is not considered a HIPAA covered entity?
Under HIPAA, which of the following is not considered a provider entity: Business associates. Us Healthcare entities are outsourcing certain services such as Transportation to foreign country. Offshore vendors are not covered and see under HIPAA and do not have to comply with HIPAA privacy and security legislation.
What should you do as a covered entity to protect PHI?
A covered entity must implement hardware, software, and/or procedural mechanisms to record and examine access and other activity in information systems that contain or use e-PHI. Integrity Controls. A covered entity must implement policies and procedures to ensure that e-PHI is not improperly altered or destroyed.
Which option below is not covered entity under HIPAA?
Which option below is not a covered entity under HIPAA? Rationale The definition of "health plan" in the HIPAA regulations exclude any policy, plan, or program that provides or pays for the cost of excepted benefits.
Who is covered by HIPAA quizlet?
Healthcare providers (including doctors, nurses, hospitals, dentists, nursing homes, and pharmacies). As a healthcare worker, you are part of the "healthcare provider" network and therefore are required to comply with HIPAA rules and regulations regarding Protected Health Information (PHI).
What is a non covered entity under HIPAA?
Non-covered entities are not subject to HIPAA regulations. Examples include: Health social media apps. Wearables such as FitBit.
What is a covered entity quizlet?
The covered entities (CEs) - health care organization that are required by law to obey HIPAA regulations. - organization that electronically transmit any information that is protected under HIPAA. these include- health plans, clearing house, and health care provider.
Who would not be considered a covered entity under HIPAA?
Are there exceptions to the definition of a HIPAA covered entity? Yes. HIPAA does not apply to employer-administered health plans with fewer than 50 participants, to some government-funded programs (i.e., the food stamp program), and to educational institutions that provide healthcare services solely for students.
Is a school that provides healthcare services for students a HIPAA Covered Entity?
Although there are some cases in which higher education institutions can be “hybrid entities”, most public schools that provide healthcare services...
Are employers Covered Entities under HIPAA if they maintain employee health records?
Generally, employers are not Covered Entities under HIPAA because employee health records maintained by an employer are not used for HIPAA-covered...
When might state laws affect who is a Covered Entity under HIPAA?
A Covered Entity will always be a Covered Entity under HIPAA, but some states have passed legislation which provides a different definition of a Co...
Does a Covered Entity have to sign a Business Associate Agreement to use Gmail?
A Covered Entity has to sign a Business Associate Agreement with every organization to whom PHI is disclosed. Therefore, if PHI is disclosed in an...
When might a criminal penalty be imposed on a Covered Entity?
To date, the penalties imposed on Covered Entities have been civil penalties. The only criminal penalties for violations of HIPAA have been for the...
What is covered under HIPAA?
Covered entities under HIPAA are individuals or entities that transmit protected health information for transactions for which the Department of Health and Human Services has adopted standards (see 45 CFR 160.103). Transactions include transmission of healthcare claims, payment and remittance advice, healthcare status, ...
What are the providers of healthcare?
Healthcare providers include hospitals, clinics, doctors, psychologists, dentists, chiropractors, nursing homes, pharmacies, home health agencies, and other providers of healthcare that transmit health information electronically. HIPAA also applies to business associates of HIPAA-covered entities and their subcontractors.
What is a healthcare transaction?
Transactions include transmission of healthcare claims, payment and remittance advice, healthcare status , coordination of benefits, enrollment and disenrollment, eligibility checks, healthcare electronic fund transfers, and referral certification and authorization.
What is a health plan?
Health plans include health insurance companies, health maintenance organizations, government programs that pay for healthcare (Medicare for example), and military and veterans’ health programs. Healthcare clearinghouses are organizations that process nonstandard health information and convert data into types that conform to ...
Can you get a fine for HIPAA violations?
If HIPAA violations have been allowed to persist for several years, or if multiple violations of HIPAA Rules are discovered, multi-million-dollar fines are possible. Criminal penalties are also possible for certain HIPAA violations.
What do the HIPAA Privacy and Security Rules require of covered entities when they dispose of protected health information?
What do the HIPAA Privacy and Security Rules require of covered entities when they dispose of protected health information? The HIPAA Privacy Rule requires that covered entities apply appropriate administrative, technical, and physical safeguards to protect the privacy of protected health information (PHI), in any form. See 45 CFR 164.530 (c).
What is the HIPAA Security Rule?
In addition, the HIPAA Security Rule requires that covered entities implement policies and procedures to address the final disposition ...
Can covered entities dispose of PHI?
Thus, covered entities are not permitted to simply abandon PHI or dispose of it in dumpsters or other containers that are accessible by the public or other unauthorized persons. However, the Privacy and Security Rules do not require a particular disposal method.
What are the steps covered entities should take to comply with HIPAA?
The following are key compliance actions that covered entities should take. 1. Assign HIPAA responsibility. Covered entities must designate persons to serve as their HIPAA privacy and security officers, and document the designation in writing. 16 The privacy and security officers are responsible for ensuring HIPAA compliance.
What are the HIPAA privacy, security, and breach notification rules?
The HIPAA Privacy, Security, and Breach Notification Rules 1 apply to healthcare providers who engage in certain electronic transactions, healthcare clearinghouses, and health plans, including employee group health plans with 50 or more participants or that are administered by a third party. 2 Covered entities must comply with HIPAA for the following reasons:
What is OCR in HIPAA?
The Office for Civil Rights (“OCR”) is required to impose HIPAA penalties if the covered entity acted with willful neglect, i.e., with “conscious, intentional failure or reckless indifference to the obligation to comply” with HIPAA requirements. 3 The following chart summarizes the tiered penalty structure 4:
How long do you have to maintain HIPAA documentation?
Documenting proper actions will help covered entities defend against HIPAA claims. Covered entities and business associates are required to maintain documentation required by HIPAA for six years from the date that the document was last in effect. 62
What is breach of business associate agreement?
Breach of the business associate agreement exposes the business associate to contract claims by the covered entity in addition to HIPAA penalties. Covered entities are generally not liable for the actions of their business associates unless the covered entity knows of a pattern of activity or practice of the business associate that constitutes a material violation of the business associate’s obligation and fails to act to cure the breach or end the violation, 41 or the business associate is acting as the agent of the covered entity. 42 To avoid liability, covered entities should ensure that business associates are acting as independent contractors, not agents of the covered entity. 43
What is a notice of privacy practices?
Notice of privacy practices. Covered entities must provide individuals with a notice of privacy practices that describes how the entity will use the individual’s PHI and contains certain required statements. 37 The OCR has published model privacy notices on its website, http://www.hhs.gov/ocr/privacy/hipaa/modelnotices.html, although most covered entities would likely prefer to use their own forms. A checklist for notices is available at this link .
Why is it important to document good faith efforts to comply with the law?
Given the increased penalties, lowered breach notification standards, and expanded enforcement, it is more important than ever for covered entities to comply or, at the very least, document good faith efforts to comply, to avoid a charge of willful neglect, mandatory penalties, and civil lawsuits.
What is HIPAA covered?
Use this tool to find out. HIPAA, or the Health Insurance Portability and Accountability Act of 1996, covers both individuals and organizations. Those who must comply with HIPAA are often called HIPAA-covered entities. HIPAA-covered entities include health plans, clearinghouses, and certain health care providers as follows:
Which government programs pay for health care?
Government programs that pay for health care, like Medicare, Medicaid, and military and veterans’ health programs
What is a health care clearinghouse?
Health care clearinghouse that translates a claim from a nonstandard format into a standard transaction on behalf of a health care provider, and forwards the processed transaction to a payer. Also, a covered health care provider, health plan, or health care clearinghouse can be a business associate of another covered entity.
Is a health care provider a business associate?
Also, a covered health care provider, health plan, or health care clearinghouse can be a business associate of another covered entity.
What are the rules and regulations of HIPAA?
HIPAA Rules and Regulations. The HIPAA rules and regulations provide guidance for the proper uses and disclosures of protected health information (PHI), how to secure PHI, and what to do if there is a PHI breach. The HIPAA rules and regulations consists of three major components, the HIPAA Privacy rules, Security rules, ...
Who must make documentation of their HIPAA practices available to the government to determine compliance?
Covered entities must make documentation of their HIPAA practices available to the government to determine compliance.
What is HIPAA law?
HIPAA law under the Privacy and Security Rules requires covered entities to notify individuals of uses of their PHI. Covered entities must also keep track of disclosures of PHI and document privacy policies and procedures. They must appoint a Privacy Official and a contact person responsible for receiving complaints and train all members of their workforce in procedures regarding PHI. An individual who believes that HIPAA Privacy Rules are not being upheld can file a complaint with the Department of Health and Human Services Office for Civil Rights (OCR), the reporting information but be available on the organizations Notice of Privacy Practices that is handed to the patient or visible in an obvious place like a doctors waiting room.
What are the three major components of HIPAA?
The HIPAA rules and regulations consists of three major components, the HIPAA Privacy rules, Security rules, and Breach Notification rules . A summary of these Rules is discussed below.
When did HIPAA go into effect?
The Security Standards were issued on February 20, 2003 but the HIPAA law went into effect on April 21, 2003 with a compliance date of April 21. The HIPAA Privacy Rule pertains to all Protected Health Information (PHI) including paper and electronic, the Security Rule deals specifically with Electronic Protected Health Information (ePHI). HIPAA Rules and Regulations lay out three types of security safeguards required for compliance: administrative, physical, and technical. For each of these types, the HIPAA Privacy Rule identifies security standards, and for each standard, it names both required and addressable implementation specifications. Required specifications must be adopted and administered as dictated by the Rule. Addressable specifications are more flexible. Individual covered entities can evaluate their own situation and determine the best way to implement addressable specifications. The HIPAA Rules and Regulations standards and specifications are as follows:
When was HIPAA enacted?
The compliance date of the HIPAA Privacy Rule was April 14, 2003 with a one-year extension for certain “small plans”. HIPAA Privacy Rules regulate the use and disclosure of Protected Health Information (PHI) held by covered entities which are defined as health care clearinghouses, employer sponsored health plans, health insurers, ...
Can a covered entity disclose PHI without a patient's authorization?
Under the HIPAA Privacy Rule, a covered entity may disclose PHI to facilitate treatment, payment, or health care operations (TPO) without a patient’s express written authorization. Any other disclosure of PHI requires the covered entity to obtain and store written authorization from the individual for the disclosure.
When was HIPAA passed?
Indeed, the concept of mobile apps and consumer devices was a fairly new one in the mid 1990s when HIPAA was passed. (To offer an illustration of this, smartphones did not offer a camera function until 2002).
How is health information collected?
Health information is now collected by apps and computer devices. The types of data collected are often exactly the same as the data collected by healthcare organizations, which are subject to the HIPAA Privacy Rule and the HIPAA Security Rule.
Does HIPAA require PHI to be protected?
Under HIPAA, BAs must safeguard PHI they handle in providing services to covered entities. If that PHI is handled through an app or device, then by definition, the app or device must be properly secured and privacy safeguards must be implemented with respect to it.
Does HIPAA apply to business associates?
HIPAA does apply to business associates of covered entities that provide apps and devices on behalf of the covered entity . If the business associate uses the app or device to perform a business function for a covered entity, and that function involves handling of PHI, the business associate is subject to the HIPAA Privacy ...
Does HIPAA cover EMRs?
While HIPAA was updated by the HITECH Act of 2009, which does cover electronic medical records (EMRs, which are sometimes referred to as EHRs, or electronic health records), HITECH does not extend to apps and devices.
Is a non-covered entity HIPAA compliant?
By definitions, non-covered entities are not subject to HIPAA regulations. Apps and consumer devices that collect protected health information (PHI), and the vendors that manufacture them, do not meet the definition of a “covered entity.”. However, a number of organizations have called for HIPAA compliance for non-covered entities, ...
Do HIPAA rules apply to apps?
However, if the app or device is not provided by a vendor acting as a business associate of a HIPAA covered entity, HIPAA Rules do not apply. A huge number of vendors that are not business associates, are the entities that are manufacturing the apps and devices.
