Comprehensive compliance requirements for healthcare providers, medical practices, hospitals, and life sciences companies operating in Massachusetts.
Massachusetts is home to world-renowned healthcare institutions including Mass General Brigham, Boston Children's Hospital, and leading academic medical centers. The state has approximately 62,000 healthcare establishments employing over 500,000 workers. Healthcare organizations in Massachusetts must comply with both state data security regulations (201 CMR 17.00, M.G.L. c. 93H) and federal healthcare-specific requirements (HIPAA, HITECH).
All companies in Massachusetts, including those in the healthcare & life sciences sector, must comply with Massachusetts data security and privacy regulations:
Pro Tip: Start with 201 CMR 17.00 - Massachusetts' foundational data security regulation that applies to all businesses handling personal information of Massachusetts residents.
These frameworks are legally required for healthcare & life sciences companies. Non-compliance can result in significant penalties, fines, and legal consequences.
Standards for the Protection of Personal Information of Residents of the Commonwealth
Massachusetts comprehensive data security regulation requiring businesses to protect personal information of Massachusetts residents.
Massachusetts General Law Chapter 93H - Notification of Security Breaches
Massachusetts law requiring notification of security breaches involving personal information.
Health Insurance Portability and Accountability Act Privacy Rule - Standards for Privacy of Individually Identifiable Health Information
Federal standard establishing national requirements for the protection of individually identifiable health information by covered entities and their business associates.
Health Insurance Portability and Accountability Act Security Rule - Security Standards for the Protection of Electronic Protected Health Information
Federal standard establishing national security requirements for protecting electronic protected health information (ePHI) created, received, maintained, or transmitted by covered entities and business associates.
Health Information Technology for Economic and Clinical Health Act
Federal law enacted as part of the American Recovery and Reinvestment Act of 2009 that strengthens HIPAA enforcement and establishes breach notification requirements.
While not legally mandatory, these frameworks represent industry best practices for healthcare & life sciences companies. Implementing these can improve security posture, build customer trust, and provide competitive advantages.
National Institute of Standards and Technology Cybersecurity Framework Version 2.0
Voluntary framework providing guidance for organizations to manage and reduce cybersecurity risk through a common language and systematic approach.
An Act to Protect Access to Confidential Healthcare (PATCH Act) - M.G.L. Chapter 176O, Section 27
Massachusetts state law allowing individuals covered under someone else's health insurance to request that billing information for sensitive healthcare services be sent directly to them, protecting their privacy from the primary policyholder.
Section 405(d) of the Cybersecurity Act of 2015 - Health Industry Cybersecurity Practices (HICP)
Voluntary federal program providing healthcare organizations with cybersecurity practices recognized by HHS as effective methods for protecting health information and reducing cybersecurity risks. Implementation for 12+ months provides favorable consideration in HIPAA enforcement.
Physician Self-Referral Law (42 USC Sec. 1395nn, 42 CFR Sec.Sec. 411.350-411.389)
The Stark Law (42 USC Sec. 1395nn) prohibits physicians from referring Medicare/Medicaid patients for designated health services (DHS) to entities with which the physician (or immediate family member) has a financial relationship, unless an exception applies. This is a strict liability law - intent is not required for a violation. **Coverage**: All physicians who order or refer designated health services for Medicare/Medicaid patients. **Key Prohibitions**: - Physician cannot refer patients to entity for DHS if financial relationship exists (ownership, compensation) - Entity cannot bill Medicare/Medicaid for services from prohibited referral - Applies to physician's immediate family members' financial relationships **Designated Health Services (DHS)**: Clinical lab, PT/OT/speech therapy, radiology, radiation therapy, DME, parenteral/enteral nutrients, prosthetics/orthotics, home health, outpatient prescription drugs, inpatient/outpatient hospital services. **Massachusetts Context**: State law (MGL Ch. 111 Sec. 53D) also prohibits certain provider self-referrals. Healthcare organizations must comply with both federal Stark Law and Massachusetts requirements.
Additional frameworks that may apply depending on your specific business operations, client requirements, or industry partnerships.
Follow this recommended sequence to achieve compliance as a Massachusetts healthcare & life sciences company.
Begin with 201 CMR 17.00 (data security) and M.G.L. c. 93H (breach notification). These apply to all Massachusetts businesses and form the foundation of your compliance program. Prepare for MDPA compliance (effective 2025).
Address all mandatory frameworks for the healthcare & life sciences sector. These are non-negotiable legal requirements with enforcement and penalties.
Strengthen your security posture with recommended frameworks. While not mandatory, these can differentiate your company, win customer trust, and may become requirements for certain contracts or partnerships.
Compliance is not a one-time project. Maintain ongoing monitoring, conduct regular assessments, update policies as regulations change, and train employees continuously. Use MyRHC to track your compliance status and stay informed of regulatory updates.
Get started with MyRHCMyRHC provides comprehensive tools and guidance for Massachusetts healthcare & life sciences companies to navigate complex compliance requirements.