Privacy and Security

Medini ensures your client's and patient's information is closely protected and abides by the polices in place for HIPAA, PHIPA and PIPEDA.

Compliance

PIPEDA

Scope:
- Applies to private-sector organizations across Canada that collect, use, or disclose personal information in the course of commercial activities.
- Also applies to employee information of federally regulated businesses.

Ten Fair Information Principles:
- Accountability: Organizations are responsible for personal information under their control and must designate an individual to ensure compliance.
- Identifying Purposes: The purposes for collecting personal information must be identified by the organization at or before the time of collection.
- Consent: The knowledge and consent of the individual are required for the collection, use, or disclosure of personal information, except where inappropriate.
- Limiting Collection: The collection of personal information must be limited to that which is necessary for the purposes identified by the organization.
- Limiting Use, Disclosure, and Retention: Personal information must not be used or disclosed for purposes other than those for which it was collected, except with the consent of the individual or as required by law.
- Accuracy: Personal information must be as accurate, complete, and up-to-date as necessary for the purposes for which it is to be used.
- Safeguards: Personal information must be protected by security safeguards appropriate to the sensitivity of the information.
- Openness: Organizations must make readily available to individuals specific information about their policies and practices relating to the management of personal information.
- Individual Access: Upon request, an individual must be informed of the existence, use, and disclosure of their personal information and be given access to that information.
- Challenging Compliance: An individual can challenge an organization's compliance with the above principles to the designated individual accountable for the organization's compliance.

Provincial Privacy Laws:
- Alberta, British Columbia, and Quebec have their own private-sector privacy laws deemed substantially similar to PIPEDA.
- In provinces with such laws, PIPEDA applies to federally regulated organizations and to personal information in interprovincial or international transactions.

Cross-Border Information:
- PIPEDA applies to personal information that crosses provincial or national borders in the course of commercial activities.

For comprehensive guidance on PIPEDA compliance, visit the Office of the Privacy Commissioner of Canada's website.

PHIPA

What PHIPA Protects:
- PHIPA applies to personal health information (PHI), including any data related to physical/mental health, healthcare services provided, payments, health numbers, and health history.
- PHI must be collected, used, and disclosed only for legitimate healthcare purposes with proper consent.
Consent Framework:
- Consent Types: Implied for routine healthcare and express for non-healthcare purposes or third-party disclosures.
- Knowledgeable Consent: Individuals must know the purpose of data use and that they can withhold or withdraw consent.
Custodians and Agents:
- Custodians: Include healthcare providers, hospitals, long-term care homes, and others responsible for PHI.
- Agents: Employees or contractors acting on behalf of custodians must comply with PHIPA.
Collection, Use, and Disclosure:
- Only collect the minimum necessary PHI for the purpose.
- Disclosure without consent is limited to specific cases, such as emergencies or legal obligations.
Access and Correction:
- Individuals have the right to access and request corrections to their PHI.
- Custodians must respond to access requests within 30 days and may refuse access only under specific conditions, such as legal privilege or risk of harm.
Security and Safeguards:
- Implement administrative, technical, and physical safeguards to prevent theft, loss, or unauthorized access to PHI.
- Notify individuals of any breaches affecting their PHI.
Breach and Enforcement:
- Violations may result in fines: up to $50,000 for individuals and $250,000 for organizations.
- The Information and Privacy Commissioner (IPC) oversees compliance and investigates complaints.
Transparency and Accountability:
- Custodians must designate a privacy officer and publish information practices for PHI management.
- Individuals must be informed of how to access their PHI, request corrections, or lodge complaints.
Data Retention and Disposal:
- PHI must be retained securely and only as long as necessary for the purpose.
- Secure disposal is required when PHI is no longer needed.
Exceptions and Special Cases:
- Disclosure without consent is allowed in cases like public health emergencies, legal investigations, or preventing serious bodily harm.
- Health information network providers have additional obligations, such as breach reporting and conducting privacy impact assessments.

HIPAA

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 is a U.S. federal law designed to protect the privacy and security of individuals' medical information while allowing the flow of health information necessary for high-quality healthcare.

Privacy Rule:
- Protects individuals' medical records and other personal health information (PHI).
- Applies to covered entities (healthcare providers, health plans, healthcare clearinghouses) and their business associates.
- Requires safeguards to ensure the confidentiality of PHI and sets limits on its use and disclosure without patient consent.
- Grants patients rights over their PHI, including the right to access and request corrections.
Security Rule:
- Focuses on electronic protected health information (ePHI).
- Requires covered entities and business associates to implement administrative, physical, and technical safeguards to ensure ePHI confidentiality, integrity, and security.
- Examples of safeguards:
  - Administrative: Security training, risk analysis, incident response plans.
  - Physical: Access controls to facilities, workstation security.
  - Technical: Encryption, secure user authentication, access control.
Breach Notification Rule:
- Requires covered entities to notify individuals, the U.S. Department of Health and Human Services (HHS), and sometimes the media of breaches of unsecured PHI.
- Business associates must notify the covered entity of any breach.
- Breaches affecting more than 500 individuals require immediate reporting to HHS.
Enforcement Rule:
- Establishes procedures for investigating HIPAA violations and sets penalties for non-compliance.
- Penalties range from $100 to $50,000 per violation, with an annual maximum of $1.5 million, depending on the level of negligence.
Omnibus Rule:
- Strengthens privacy and security protections.
- Extends compliance obligations to business associates and subcontractors.
- Introduces new requirements for PHI usage in marketing, fundraising, and research.

Who Must Comply with HIPAA?

Covered Entities:
- Healthcare providers (e.g., doctors, hospitals, clinics).
- Health plans (e.g., insurance companies, Medicare).
- Healthcare clearinghouses (e.g., entities processing health information).
Business Associates:
- Companies or individuals handling PHI on behalf of covered entities (e.g., billing companies, cloud storage providers).
Subcontractors:
- Entities that perform functions involving PHI for business associates.

Steps to Achieve HIPAA Compliance

Risk Assessment:
- Conduct regular risk analyses to identify vulnerabilities in handling PHI.
Develop Policies and Procedures:
- Establish clear guidelines for using, disclosing, and safeguarding PHI.
Employee Training:
- Train staff on HIPAA requirements and internal policies.
Implement Safeguards:
- Administrative, physical, and technical safeguards tailored to the organization’s needs.
Sign Business Associate Agreements (BAAs):
- Ensure all business associates and subcontractors comply with HIPAA.
Breach Management and Reporting:
- Develop a plan for identifying, mitigating, and reporting breaches.
Documentation and Audits:
- Maintain records of compliance efforts and be prepared for HHS audits.

Common HIPAA Violations

Failing to encrypt ePHI or use secure communication methods.
Unauthorized access to PHI by employees.
Lack of a Business Associate Agreement with vendors.
Failure to notify HHS or affected individuals of a breach.
Insufficient access controls (e.g., shared passwords).

Why is HIPAA Compliance Important?

Patient Trust: Ensures the confidentiality of patient information.
Legal Obligation: Avoids costly fines and legal actions.
Reputation: Protects the organization’s credibility and integrity.
Operational Efficiency: Reduces risks associated with data breaches and non-compliance.