Navigating and implementing HIPAA compliance for healthcare providers can be complex, overwhelming, and demanding at the same time. However, it’s essential for anyone with access to patient information to understand and comply with this vital legal and ethical framework. SAAS solutions like AffableBPM offer a secure document repository, granting authorized users access to the information relevant to their roles. To address common misconceptions and questions, we’ve created this article to provide a clear and concise guide to HIPAA standards and provisions.
HIPAA Simplified: Essential Points
In a nutshell, HIPAA, which stands for Health Insurance Portability and Accountability Act, was enacted in 1996 to modernize healthcare information flow and protect patient medical data. Here are the key aspects of HIPAA:
- Facilitates seamless health insurance coverage transfer for individuals changing or losing jobs in the USA.
- Combats healthcare fraud and abuse.
- Mandates secure electronic access to billing, claims, referrals, and other processes for healthcare organizations.
- Sets standards for the transmission and handling of patient information.
HIPAA comprises five titles:
- Health Care Access, Portability, and Renewability: Regulates health insurance coverage availability for workers and their families during job transitions.
- Administrative Simplification: Provisions, establishes national standards for electronic health care transactions and all covered entities to ensure privacy and security of individually identifiable health information.
- Tax Related Health Provisions: Provides guidelines for pre-tax medical spending accounts.
- Application & Enforcement of Group Health Plan Requirements: Outlines rules for group health plans.
- Revenue Offsets: governs company-owned life insurance policies.
In essence, HIPAA safeguards patient information, preventing misuse, theft, or embezzlement of personal healthcare data.
What is a Covered Entity?
“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 (Health and Human Services) has adopted standards. Generally, these transactions concern billing and payment for services or insurance coverage.” 
What is a Business Associate?
A “business associate” refers to an individual or organization that performs specific functions or activities involving the use or disclosure of Protected Health Information (PHI) on behalf of a covered entity.  Examples of business associates include lawyers, accountants, IT contractors, billing companies, cloud storage services, and email encryption services, among others. Before accessing PHI, a business associate must sign a Business Associate Agreement with the covered entity. This agreement outlines the specific PHI they can access, how it should be used, and the requirement to return or destroy the information once the task is completed. While in possession of PHI, the business associate shares the same HIPAA compliance obligations as a covered entity.
Understanding HIPAA Compliance
4 Key HIPAA Compliance Guidelines for Healthcare Providers are as follows:
- Privacy Rules
- Security Rules
- Breach Notification Rules
- Enforcement Rules
Under HIPAA privacy rules, healthcare providers are obligated to grant individuals access to their Protected Health Information (PHI), which encompasses health conditions, treatment plans, notes, images, lab results, and billing details. The privacy rule outlines the permissible uses and disclosures of PHI by healthcare professionals, lawyers, and other authorized entities. It applies to all forms of PHI, whether stored or transmitted electronically, on paper, or through oral communication by a covered entity or its business associates.
The HIPAA Security Rule works hand-in-hand with the Privacy Rule to establish the necessary national standards for covered entities in handling electronic Protected Health Information (ePHI). This rule focuses on safeguarding ePHI through various measures. “The Security Rule requires appropriate administrative, physical and technical safeguards to ensure the confidentiality, integrity, and security of ePHI.” 
The HIPAA Security Rule consists of three categories with specific standards, which are detailed below: 
- Technical Safeguards: Technical safeguards focus on the technology used to protect ePHI within covered entities. It is crucial for covered entities to comply with the Technical Safeguard standards and implementation specifications outlined in the Security Rule. Following are the Key Standards:
- Access Controls: Providing unique user identification, emergency access procedures, automated session termination, and encryption/decryption methods for ePHI storage are some of the important considerations to ensure proper access control to ePHI.
- Audit Controls: Regular assessment, recording, and storage of system usage and ePHI handling through audit reports or similar mechanisms are a must to determine occurrence of a security violation.
- Integrity Controls: Implementing policies and procedures from both technical and non-technical compromise is necessary to protect ePHI. A periodic risk analysis and mitigation measures are required to be conducted on a regular basis by covered entities.
- Person or Entity Authentication: Establishing authentication measures (e.g., passwords, smart cards, biometric safeguards) to ensure authorized access to information and ePHI is a must.
- Transmission Security: Allows ePHI to be transmitted over protected electronic open networks, using implementation specifications such as integrity controls and/or encryption mechanism. 
- Physical Safeguards: The Physical Safeguards address the physical access to ePHI regardless of its storage location, whether it’s a remote data center, cloud environment, or on-site servers of the HIPAA covered entity. These safeguards also provide guidelines on securing workstations and mobile devices to prevent unauthorized access.  The following are the key standards as part of Physical Safeguards.
- Facility Access Controls: Policies and procedures must be in place to restrict physical access to electronic information systems and the facilities where they are housed. These measures ensure that only authorized personnel are granted access while maintaining the necessary security protocols.
- Workstation Use: Lists policies and procedures that define the specific functions to be performed, the appropriate manner of performing those functions, and the physical attributes of the workstation environment. A workstation is defined in the rule as “an electronic computing device, for example, a laptop or desktop computer, or any other device that performs similar functions, and electronic media stored in its immediate environment.” 
- Workstation Security: Workstation Security entails implementing physical safeguards for all workstations that access ePHI to prevent unauthorized access. It complements the Workstation Use standard, by specifically focusing on securing workstations from unauthorized users through physical measures.
- Device and Media Controls: The Device and Media Controls standard mandates the establishment of policies and procedures to manage the receipt, removal, and movement of hardware and electronic media containing ePHI. This includes controlling the entry and exit of such items from a facility, as well as their internal movement within the facility. The goal is to ensure proper safeguards and control measures are in place to protect the confidentiality, integrity, and security of ePHI stored on devices and media.
- Administrative Safeguards: The Administrative Safeguards encompass the policies and procedures that bridge the Privacy Rule and the Security Rule. These safeguards mandate the appointment of a Security Officer and a Privacy Officer who are responsible for implementing measures to protect ePHI. They also have the responsibility of overseeing the workforce’s adherence to privacy and security guidelines. Following are the Key Standards 
- Security Management Process: This Process mandates that covered entities establish policies and procedures to prevent, detect, contain, and correct security violations. It consists of four specific implementation specifications:
- Risk Analysis: Conducting a thorough assessment of potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI.
- Risk Management: Implementing measures to mitigate identified risks and vulnerabilities, ensuring the ongoing protection of ePHI.
- Sanction Policy: Enforcing appropriate sanctions against workforce members who violate the security policies and procedures of the covered entity.
- Information System Activity Review: Regularly reviewing information system activity through activities such as auditing logs, access reports, and tracking security incidents.
- Assigned Security Responsibility: It is crucial to designate a security official who is responsible for consistently reviewing, developing, and maintaining privacy policies and strategies. This individual plays a vital role in ensuring compliance with privacy guidelines.
- Workforce Security: To maintain appropriate access controls and prevent unauthorized access to ePHI, it is essential to ensure that only authorized individuals have the necessary access privileges while preventing unauthorized personnel from obtaining access to ePHI.
- Security Awareness and Training: Security awareness and training play a critical role in ensuring the effectiveness of safeguards, given that many security risks and vulnerabilities originate internally. Covered entities are required to establish a comprehensive security awareness and training program for all workforce members, including management.
- Evaluation System: To ensure the ongoing effectiveness of security plans and procedures in protecting ePHI, it is crucial for a covered entity to assess employees’ adherence to ePHI handling practices and identify areas for improvement. Regular monitoring and evaluation of policies and procedures help maintain compliance and proactively address any potential vulnerabilities or gaps in security measures.
Breach Notification Rule
Under the HIPAA Breach Notification Rule, covered entities are obligated to inform individuals within 60 days if there has been unauthorized access to their PHI. It’s important to note that even if ePHI is encrypted by ransomware, it is still considered a breach and falls under this rule. If the breach affects more than 500 PHI records, the covered entity must notify the Department of Health and Human Services, which may involve the Office for Civil Rights (OCR). Additionally, in such cases, the covered entity is required to issue a press release about the breach to inform the public. 
The Enforcement Rule outlines the compliance responsibilities of covered entities in terms of cooperation during the enforcement process. When individuals or organizations report HIPAA violations to the Office for Civil Rights (OCR), the OCR is responsible for investigating and reviewing those reported violations. The Enforcement Rule sets forth guidelines for determining the amount of civil penalties in case of a violation and establishes procedures for hearings and appeals if a covered entity contests a violation determination. It ensures a fair and structured enforcement process for addressing HIPAA violations and resolving disputes.
Covered entities should be aware of the following penalties as per the violation tier:
- Tier 1: A violation attributable to ignorance can attract a fine of $127 – $31,98750,000.
- Tier 2: A violation which occurred despite reasonable vigilance can attract a fine of $1,280 – $563,973.
- Tier 3: A violation due to willful neglect which is corrected within thirty days will attract a fine of between $12,794 and $63,973.
- Tier 4: A violation due to willful neglect which is not corrected within thirty days will attract the minimum fine of $63,973.
Fines for HIPAA violations are assessed based on various factors, including the category of violation, the number of records exposed in a breach, the level of risk associated with the data exposure, and the degree of negligence demonstrated. The maximum fine per year for the most serious Tier 4 violation can reach up to $1,919,173. In cases of willful neglect, criminal charges can also be filed. Additionally, victims of a breach have the option to pursue civil lawsuits to seek damages. The entities most commonly subject to enforcement include private medical practices, hospitals, outpatient facilities such as pain clinics or rehabilitation centers, insurance groups, and pharmacies. It is crucial for these organizations to prioritize HIPAA compliance to mitigate the risk of penalties and legal consequences.
Understanding HIPAA Violation
HIPAA requirements can be violated in various ways, with the most common being negligence or incomplete compliance, leading to data breaches, unauthorized release ofPHI, or access by unauthorized employees. HIPAA violations can persist for extended periods, often going unnoticed for months or even years. The penalties for such violations increase as their duration extends. Therefore, it is crucial for HIPAA-covered entities to conduct regular compliance reviews to proactively identify and address any potential violations before they are discovered by regulatory authorities.
There are three main ways that HIPAA violations are discovered: 
- Investigations into a data breach by OCR (or state attorneys general)
- Investigations into complaints about covered entities and business associates
- HIPAA compliance audits
Even in cases where a data breach does not directly involve a HIPAA violation or a complaint is found to be unfounded, the Office for Civil Rights (OCR) may still uncover unrelated HIPAA violations during their investigations. If such violations are discovered and deemed significant, they may lead to the imposition of financial penalties or other enforcement actions. 
HIPAA Risk Assessment
Within the HIPAA regulations, there is a notable absence of specific guidance on the content and components of a HIPAA risk assessment. However, the Department of Health and Human Services emphasizes that the purpose of a HIPAA risk assessment is for a Business Associate to proactively evaluate their organization internally and identify potential vulnerabilities, threats, and risks related to PHI they handle. While the exact approach may vary depending on the organization, here are some common objectives of a HIPAA risk assessment:
- Identify PHI: One of the objectives of a HIPAA risk assessment is to identify the PHI that your organization creates, receives, stores, and transmits. This includes not only the PHI handled internally but also the PHI shared with consultants, vendors, and business associates.
- Identify Potential Vulnerabilities: Assess the systems, processes, and infrastructure within the organization to identify any potential weaknesses or vulnerabilities that could compromise the security or privacy of PHI.
- Evaluate Threats: Determine the various internal and external threats that could potentially lead to unauthorized access, disclosure, or loss of PHI. This includes considering factors such as cyber threats, physical security risks, and human factors.
- Assess Risks: Analyze the likelihood and impact of identified threats to PHI, taking into account the potential harm to individuals, legal and financial consequences, and the organization’s reputation.
- Mitigation Strategies: Develop and implement strategies and controls to mitigate identified risks and vulnerabilities. This may involve implementing technical safeguards, security policies and procedures, training programs, and incident response plans.
- Documentation and Compliance: Maintain thorough documentation of the risk assessment process, findings, and actions taken to address identified risks. Ensure ongoing compliance with HIPAA regulations and regularly review and update risk assessments as needed.
“The HIPAA risk assessment, the rationale for the measures, procedures, and policies subsequently implemented, and all policy documents must be retained for a minimum of six years.” 
HIPAA compliance is about fostering trust with customers by safeguarding their data. Compliance with HIPAA is an ongoing commitment, requiring continuous efforts rather than a one-time assessment. It is essential for Covered Entities and Business Associates to remain vigilant in their understanding and implementation of HIPAA requirements. Healthcare solution such as AffableBPM, based on HIPAA compliant Microsoft Azure services, make contractual assurances about data safeguarding, reporting including breach notifications and data access in accordance with HIPAA.  Seeking professional advice is highly recommended if any aspect of HIPAA raises concerns or uncertainties. Ignorance of HIPAA does not serve as an excuse for noncompliance, and the responsibility to comprehend, adopt, and maintain HIPAA guidelines is significant. Prioritizing compliance is crucial for the long-term success and reputation of organizations handling PHI.