👀Legal Aspects of Healthcare Unit 3 – HIPAA: Health Data Privacy & Security

What's HIPAA All About?

• HIPAA stands for the Health Insurance Portability and Accountability Act, a federal law enacted in 1996 to protect sensitive patient health information
• Establishes national standards for the security of electronic protected health information (ePHI) and the confidentiality provisions of the Patient Safety Rule
• Requires covered entities to implement safeguards to ensure the confidentiality, integrity, and availability of ePHI
• Mandates that covered entities and their business associates enter into contracts to ensure that the business associates will appropriately safeguard ePHI
• Gives patients rights over their health information, including the right to obtain a copy of their health records and to request corrections
• Empowers the Department of Health and Human Services (HHS) to enforce HIPAA through civil and criminal penalties for violations
• Aims to strike a balance between protecting patient privacy and allowing the flow of health information needed to provide high-quality healthcare

Key HIPAA Rules and Regulations

• Privacy Rule sets national standards for the protection of individuals' medical records and other personal health information
  • Requires appropriate safeguards to protect the privacy of personal health information
  • Sets limits and conditions on the uses and disclosures of such information without patient authorization
• Security Rule establishes national standards to protect individuals' electronic personal health information created, received, used, or maintained by a covered entity
  • Requires appropriate administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and security of ePHI
• Enforcement Rule provides standards for the enforcement of all the Administrative Simplification Rules
• Breach Notification Rule requires covered entities and their business associates to provide notification following a breach of unsecured protected health information
• Omnibus Rule further enhances a patient's privacy protections, provides individuals new rights to their health information, and strengthens the government's ability to enforce the law

Who Needs to Follow HIPAA?

• Covered entities include health plans, healthcare clearinghouses, and healthcare providers who electronically transmit any health information in connection with transactions for which HHS has adopted standards
  • Examples: hospitals, academic medical centers, physicians, and other healthcare providers
• Business associates are individuals or entities that perform certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provide services to, a covered entity
  • Examples: third-party administrators, pharmacy benefit managers, claims processing, data analysis, utilization review, and billing
• Subcontractors are individuals or entities to whom a business associate delegates a function, activity, or service, other than in the capacity of a member of the workforce of such business associate
• Covered entities and business associates must enter into contracts or other arrangements that comply with HIPAA to ensure that the business associate will adequately protect PHI

Protected Health Information (PHI) Explained

• PHI is any information held by a covered entity which concerns health status, the provision of healthcare, or payment for healthcare that can be linked to an individual
• Includes many common identifiers such as name, address, birth date, and Social Security Number when they can be associated with health information
• PHI includes medical records, hospital bills, health plan information, and most other individually identifiable health information used or disclosed by covered entities during the provision of healthcare
• PHI can be in any form or medium, including electronic, paper, or oral
• De-identified health information, which neither identifies nor provides a reasonable basis to identify an individual, is not considered PHI
  • Two methods to de-identify PHI: Safe Harbor method (removal of 18 types of identifiers) and Expert Determination method (a qualified expert determines the risk of re-identification is very small)

Patient Rights Under HIPAA

• Right to receive a Notice of Privacy Practices from their healthcare providers and health plans
• Right to access, inspect, and obtain a copy of their PHI in a designated record set
  • Covered entities must provide access within 30 days of a request (with some exceptions)
• Right to request an amendment to their PHI if they believe it is inaccurate or incomplete
• Right to an accounting of disclosures of their PHI made by a covered entity or its business associates in the past six years
• Right to request restrictions on certain uses and disclosures of their PHI
  • Covered entities are not required to agree to these requests, except in limited circumstances
• Right to request confidential communications of their PHI by alternative means or at alternative locations
• Right to receive notifications of breaches of their unsecured PHI
• Right to file a complaint with the covered entity or the HHS Office for Civil Rights if they believe their HIPAA rights have been violated

Security Measures and Best Practices

• Administrative safeguards are administrative actions, policies, and procedures to manage the selection, development, implementation, and maintenance of security measures
  • Examples: security management process, workforce security, information access management, and security awareness and training
• Physical safeguards are physical measures, policies, and procedures to protect a covered entity's electronic information systems and related buildings and equipment from natural and environmental hazards and unauthorized intrusion
  • Examples: facility access controls, workstation use and security, and device and media controls
• Technical safeguards are the technology and the policies and procedures for its use that protect ePHI and control access to it
  • Examples: access control, audit controls, integrity controls, and transmission security
• Organizational requirements include contracts or other arrangements between covered entities and business associates that are required to comply with HIPAA
• Policies and procedures must be implemented to comply with HIPAA standards, and they must be maintained in written form (which may be electronic)
• Regular risk assessments should be conducted to identify potential vulnerabilities and threats to the confidentiality, integrity, and availability of ePHI

Common HIPAA Violations and Consequences

• Impermissible uses and disclosures of PHI, such as unauthorized access or sharing of PHI with unauthorized individuals
• Lack of safeguards for PHI, including failure to implement appropriate administrative, physical, and technical safeguards
• Lack of patient access to their PHI, such as denying patients access to their medical records or failing to provide access within the required timeframe
• Lack of administrative safeguards, such as not conducting risk assessments or not having written policies and procedures
• Improper disposal of PHI, such as throwing away documents containing PHI without properly shredding them
• Consequences for HIPAA violations can include:
  • Civil penalties ranging from $100 to$50,000 per violation, with an annual maximum of $1.5 million for identical violations
  • Criminal penalties including fines up to $250,000 and imprisonment up to 10 years
  • Corrective action plans to address deficiencies and prevent future violations
  • Mandatory HHS monitoring for serious violations
  • Negative publicity and reputational damage

HIPAA in the Digital Age

• The increasing use of electronic health records (EHRs) and health information exchanges has made protecting ePHI more complex and challenging
• Cloud computing and the use of mobile devices in healthcare settings have introduced new risks and vulnerabilities for ePHI
  • Covered entities and business associates must ensure that ePHI is properly secured when using these technologies
• Cybersecurity threats, such as hacking, malware, and ransomware attacks, pose significant risks to the confidentiality, integrity, and availability of ePHI
  • Regular security risk assessments, employee training, and robust cybersecurity measures are essential to protect against these threats
• Telemedicine and remote patient monitoring have become more prevalent, particularly during the COVID-19 pandemic, raising new HIPAA considerations
  • Covered entities must ensure that these services are provided in a HIPAA-compliant manner, including using secure communication platforms and obtaining patient consent
• Wearable devices and mobile health apps that collect and share health data may be subject to HIPAA if they are used by covered entities or their business associates
• Genetic information is considered PHI under HIPAA and must be protected accordingly, with additional protections provided by the Genetic Information Nondiscrimination Act (GINA)
• The increasing interconnectedness of healthcare systems and the use of big data analytics present both opportunities for improving healthcare and challenges for protecting patient privacy under HIPAA