Health Care Provider Responsibilities

Covered Entities

Healthcare Providers include doctors, clinics, pharmacies, nursing homes, and dentists

As we mentioned in the course introduction, covered entities can be institutions, organizations, or persons, and include the following:

• Health Plans - including health insurance companies, HMOs, company health plans, and government programs that pay for health care, such as Medicare and Medicaid.
• Health care clearinghouses - entities that process nonstandard health information they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa.
• Health care providers - most doctors, clinics, hospitals, psychologists, chiropractors, nursing homes, pharmacies, and dentists, but only only if they transmit information in an electronic form in connection with a transaction for which HHS has adopted a standard.
• Business associates - including private sector vendors and third-party administrators.

Non-covered Entities

Non-covered entities are not subject to HIPAA regulations. However, the American Medical Association (AMA) now requires non-HIPAA-covered entities to protect sensitive Patient Health Information (PHI) they collect. The law requires that they ensure the products or services they use don’t compromise patient privacy. Examples include:

• A public health authority (states.aarp.org)
• Personal Health Record (PHR) vendors
• Personal record storage such as exercise and calories intake log
• Providers who don’t have any records in electronic forms, such as some counselors

To determine your covered-entity status, visit the Centers Medicare and Medicaid Services (cms.gov)

Health Care Providers

Transactions are usually transmitted electronically.

Every health care provider, regardless of size, who electronically transmits health information in connection with certain transactions, is a covered entity. These transactions include the following:

• claims
• benefit eligibility inquiries
• referral authorization requests
• other transactions for which HHS has established standards under the HIPAA Transactions Rule

Using electronic technology, such as email, does not mean a health care provider is a covered entity; the transmission must be in connection with a standard transaction.

The Privacy Rule covers a health care provider whether it electronically transmits these transactions directly or uses a billing service or other third party to do so on its behalf. Health care providers include all "providers of services" (e.g., institutional providers such as hospitals) and "providers of medical or health services" (e.g., non-institutional providers such as physicians, dentists and other practitioners) as defined by Medicare, and any other person or organization that furnishes, bills, or is paid for health care.

Electronic Protected Health Information

HIPAA protects individually identifiable health information.

The HIPAA Privacy Rule protects the privacy of individually identifiable health information, called protected health information (PHI), as explained in the Privacy Rule. The Security Rule protects the information covered by the Privacy Rule, which is all individually identifiable health information a covered entity creates, receives, maintains or transmits in electronic form. The Security Rule calls this information "electronic protected health information" (e-PHI). The Security Rule does not apply to PHI transmitted orally or in writing.

General Rules

The Security Rule requires covered entities to maintain reasonable and appropriate administrative, technical, and physical safeguards for protecting e-PHI.

Specifically, covered entities must:

• Ensure the confidentiality, integrity, and availability of all e-PHI they create, receive, maintain or transmit.
• Identify and protect against reasonably anticipated threats to the security or integrity of the information.
• Protect against reasonably anticipated, impermissible uses or disclosures.
• Ensure compliance by their workforce.

General Rules (Continued)

Confidentiality - e-PHI is not available or disclosed to unauthorized persons.

The Security Rule defines "confidentiality" to mean that e-PHI is not available or disclosed to unauthorized persons. The Security Rule's confidentiality requirements support the Privacy Rule's prohibitions against improper uses and disclosures of PHI.

Let’s take a look at a scenario about disclosing information to others inappropriately.

Scenario

Situation: Joan works in a cardiology practice. The physicians in the practice admit patients to a local hospital. Joan schedules a hospital admission for a friend, Nell, who attends the same church as Joan. At church the following Sunday, several members ask Joan if she knows anything about Nell’s condition. How should Joan respond?

Response: Joan must not disclose any information about Nell obtained as a result of her work in the cardiology practice, not even with Joan’s family or friends. Joan should politely inform the concerned church members that federal laws prohibit the sharing of confidential information about patients without their expressed permission.

Integrity vs. Availability

Availability means e-PHI is accessible and usable by authorized persons.

The Security Rule also promotes the two additional goals of maintaining the integrity and availability of e-PHI. Under the Security Rule:

• "integrity" means e-PHI is not altered or destroyed in an unauthorized manner.
• "Availability" means e-PHI is accessible and usable on demand by an authorized person.

HHS recognizes covered entities range from the smallest provider to the largest, multi-state health plan. Therefore, the Security Rule is flexible and scalable to allow covered entities to analyze their own needs and implement solutions appropriate for their specific environments. What is appropriate for a particular covered entity will depend on the nature of the covered entity’s business, as well as the covered entity’s size and resources.

Therefore, when a covered entity is deciding which security measures to use, the Rule does not dictate those measures but requires the covered entity to consider:

• its size, complexity, and capabilities
• its technical, hardware, and software infrastructure
• the costs of security measures
• the likelihood and possible impact of potential risks to e-PHI

Covered entities must review and modify their security measures to continue protecting e-PHI in a changing environment.

Risk Analysis and Management

HIPAA requires health care providers to conduct risk analysis.

The Administrative Safeguards provisions in the HIPAA Security Rule require covered entities to perform a risk analysis as part of their security management processes.

A risk analysis process includes, but is not limited to, the following activities:

• Evaluating the likelihood and impact of potential risks to e-PHI.
• Implementing appropriate administrative, physical, and technical security measures to address the risks identified in the risk analysis.
• Documenting the chosen security measures and, where required, the rationale for adopting those measures.
• Maintaining continuous, reasonable, and appropriate security protections.

Risk analysis should be an ongoing process, in which a covered entity regularly reviews its records to track access to e-PHI and detect security incidents, periodically evaluates the effectiveness of security measures put in place, and regularly reevaluates potential risks to e-PHI.

Safeguards

Ensure HIPAA security through administrative, physical, and technical safeguards.

There are several administrative, physical, and technical safeguards that should be put into place to protect the security of e-PHI.

Administrative Safeguards. Here are a few examples of recommended administrative safeguards:

• Security Management Process. A covered entity must identify and analyze potential risks to e-PHI, and it must implement security measures that reduce risks and vulnerabilities to a reasonable and appropriate level.
• Security Personnel: A covered entity must designate a security official who is responsible for developing and implementing its security policies and procedures.
• Information Access Management: Consistent with the Privacy Rule standard limiting uses and disclosures of PHI to the "minimum necessary," the Security Rule requires a covered entity to implement policies and procedures for authorizing access to e-PHI only when such access is appropriate based on the user or recipient's role (role-based access).
• Workforce Training and Management: A covered entity must provide for appropriate authorization and supervision of workforce members who work with e-PHI. A covered entity must train all workforce members regarding its security policies and procedures, and must have and apply appropriate sanctions against workforce members who violate its policies and procedures.
• Evaluation: A covered entity must perform a periodic assessment of how well its security policies and procedures meet the requirements of the Security Rule.

Physical Safeguards. Here are examples of physical safeguards that can be implemented:

• Facility Access and Control. A covered entity must limit physical access to its facilities while ensuring that authorized access is allowed.
• Workstation and Device Security. A covered entity must implement policies and procedures to specify proper use of and access to workstations and electronic media. A covered entity also must have in place policies and procedures regarding the transfer, removal, disposal, and re-use of electronic media, to ensure appropriate protection of electronic protected health information (e-PHI).

Safeguards (Continued)

Ensure unauthorized access to e-PHI with transmission security.

Technical Safeguards. Here are examples of technical safeguards that can be implemented to protect e-PHI:

• Access Controls: A covered entity must implement technical policies and procedures that allow only authorized persons to access electronic protected health information (e-PHI).
• Audit Controls: 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. Electronic measures must be put in place to confirm that e-PHI has not been improperly altered or destroyed.
• Transmission Security: A covered entity must implement technical security measures that guard against unauthorized access to e-PHI that is being transmitted over an electronic network.

Organizational Requirements

If a covered entity knows of an activity or practice of the business associate that constitutes a material breach or violation of the business associate’s obligation, the covered entity must take reasonable steps to cure the breach or end the violation. Violations include the failure to implement safeguards that reasonably and appropriately protect e-PHI.

Policies, Procedures, and Documentation Requirements

Covered entities must develop, adopt, and maintain HIPAA Security Rule policies and procedures.

HIPAA provisions require covered entities to develop and maintain policies, procedures, and documentation to comply with the Security Rule. A covered entity must:

• adopt reasonable and appropriate policies and procedures to comply with the provisions of the Security Rule.
• maintain written security policies and procedures and written records of required actions, activities or assessments.
• maintain written security policies, procedures, and records of required actions, activities or assessments for six years after the date of creation or last effective date, whichever is later.
• periodically review and update its documentation in response to environmental or organizational changes that affect the security of electronic protected health information (e-PHI).

State Law

The federal government can impose fines and penalties for non-compliance.

In general, state laws contrary to the HIPAA regulations are preempted by the federal requirements, which means the federal requirements will apply. "Contrary" means it would be impossible for a covered entity to comply with both the state and federal requirements, or the provision of state law is an obstacle to accomplishing the full purposes and objectives of the HIPAA provisions.

Enforcement and Penalties for Non-Compliance

If a covered entity’s employees and/or volunteers do NOT follow the rules set out by HIPAA, the federal government has the right to do the following:

• conduct an investigation
• impose fines and/or jail sentences, if found guilty

Civil Penalties

Unintentional HIPAA violations could result in monetary penalties. Health and Human Services may not impose a civil money penalty under specific circumstances, such as when a violation is due to reasonable cause and did not involve willful neglect and the covered entity corrected the violation within 30 days of when it knew or should have known of the violation.

Criminal Penalties

Knowingly making unauthorized disclosure of PHI, intentionally selling information, and offenses that include false pretenses may result in substantial fines ($50,000 - $250,000) and/or imprisonment. The U.S. Department of Justice will enforce the criminal sanctions.

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