
Privacy & HIPAA Compliance - Key Item 2
The Cancer Care Hub, as a platform handling protected health information (PHI) through its Connect App, voice cloning technology, and community engagement features, is likely considered a covered entity or business associate under HIPAA, depending on its operational structure.
Below are the key HIPAA compliance requirements tailored to our platform’s features, and the work practices employed.
Once legal counsel has been sought, we’ll update this page accordingly.
The Cancer Care Hub, a decentralized, blockchain-based platform with features like the Connect App, CancerCareCoin, voice cloning, and Warrior & Caregiver Awards, handles protected health information (PHI) (e.g., patient data, voice recordings, or tokenized testimonials). To avoid liability and protect patient record privacy, it must comply with HIPAA. Below are the requirements tailored to the platform’s operations:
Privacy Rule:
Encrypt PHI across all platform components, including the Connect App’s secure chats, voice cloning data (voice and video), and tokenized records in Warrior & Caregiver Awards. Ensure blockchain transactions (e.g., CancerCareCoin or NFTs) do not expose PHI, using off-chain storage with encrypted references.
Allow patients to access, correct, and receive an accounting of disclosures for their PHI (e.g., data in the Connect App or cloned voices). Provide a Notice of Privacy Practices (NPP) explaining PHI use across features, including global sharing or AI processing.
Limit PHI use to essential functions, such as personalized tools in the Connect App or eligibility checks for tokenized rewards. De-identify testimonials in Warrior & Caregiver Awards unless explicit consent is obtained.
Security Rule:
Conduct risk assessments for all systems (Connect App, blockchain, voice cloning AI) to identify privacy risks, such as unencrypted data or smart contract vulnerabilities. Appoint a HIPAA security officer to oversee platform-wide compliance. Develop policies to protect patient records without assuming user-facing support.
Secure servers, cloud infrastructure, and devices processing PHI (e.g., for voice cloning or blockchain nodes) with access controls.
Implement end-to-end encryption, multi-factor authentication, and audit logs for PHI access. For blockchain (CancerCareCoin, NFTs), use private or permissioned networks (e.g., Hyperledger) and store PHI off-chain to prevent public exposure. Ensure voice cloning systems use secure APIs and data deletion protocols to protect biometric data.
Breach Notification Rule:
Notify affected individuals, HHS, and potentially the media within 60 days of a PHI breach (e.g., hacked Connect App data or voice cloning server). Retain documentation for six years.
Leverage blockchain’s immutable logs to trace breaches while ensuring notification systems meet HIPAA timelines and privacy standards.
Business Associate Agreements (BAAs):
Execute BAAs with all vendors, including blockchain developers (CancerCareCoin), AI providers (voice cloning), and cloud services (Connect App). BAAs must enforce HIPAA compliance and mandate immediate breach reporting to avoid liability.
Require vendors to implement privacy-preserving technologies (e.g., zero-knowledge proofs for blockchain) to protect patient records.
Enforcement and Penalties:
Noncompliance risks fines of $100–$50,000 per violation, up to $1.5 million annually. Willful neglect increases liability.
Establish a compliance dashboard to monitor HIPAA adherence across features, reducing legal exposure.
Training and Documentation:
Train operational staff (developers, administrators) on HIPAA for PHI handling in the Connect App, blockchain, and voice cloning, focusing on privacy protection. Exclude user-facing support training. Retain training records for six years.
Document risk assessments, policies, BAAs, and consent forms.
Special Considerations for Blockchain, AI, and Global Reach:
Use private blockchains for CancerCareCoin and NFT transactions to restrict PHI access. Store all PHI off-chain with encrypted, hashed pointers, ensuring no patient data is publicly accessible on immutable ledgers. (Applications of Blockchain Technology for Data-Sharing in Oncology: Results from a Systematic Literature Review)
Obtain explicit patient consent for voice cloning data processing, including translation into 20+ languages. Implement secure deletion after use and transparent AI policies to protect biometric privacy and avoid liability.
Align with GDPR, CCPA, and other privacy laws for global users. Configure systems to enforce consent and data minimization, ensuring compliance with the strictest standards to protect patient records internationally.