Massachusetts Phi: Laws And Compliance

what laws and regulations apply to phi in massachusetts

In Massachusetts, the Health Insurance Portability and Accountability Act (HIPAA) is a federal law that protects the privacy of medical records and information. While some states have their own privacy laws, Massachusetts does not. However, the state does have specific breach notification laws that are not outlined in HIPAA.

HIPAA limits who healthcare providers can share medical information with. Providers can only share this information with other parties if the patient gives written permission by filling out an Authorization for Release of Information form.

HIPAA also requires healthcare organizations to implement a HIPAA compliance program and conduct six self-audits annually to identify security risks. They must also implement written policies and procedures that are customized for their organization's specific needs.

In addition, HIPAA imposes employee training requirements, which include annual training for all employees with access to protected health information (PHI). Employees must legally attest that they understand and agree to adhere to the training material.

Business associate agreements must also be signed with all business associate vendors, which are defined as any entity that performs a service for the practice that gives them the potential to access PHI.

To comply with the HIPAA Breach Notification Rule, healthcare organizations must have a system to detect, respond to, and report breaches.

Characteristics Values
Federal Law HIPAA (Health Insurance Portability and Accountability Act)
State Law Massachusetts does not have its own privacy laws.
Breach Notification Laws Massachusetts has specific breach notification laws not outlined in HIPAA.
Compliance Healthcare organizations must implement a HIPAA compliance program.
Security Risk Assessments Healthcare organizations must conduct six self-audits annually.
Remediation Remediation plans must list identified deficiencies and how to address them.
HIPAA Policies and Procedures Must be written and customized for the practice's specific needs.
Annual Review Policies and procedures must be reviewed annually and amended where appropriate.
HIPAA Training Must be provided to each employee with access to PHI.
Business Associate Agreements Must be signed with each business associate vendor.
Massachusetts HIPAA Form Required under certain circumstances.
Massachusetts Data Breach Notification Law Requires breached organizations to report the incident.

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Massachusetts breach notification laws

In Massachusetts, specific breach notification laws apply to businesses and organizations that own or license the personal information of its residents. These laws are in addition to the federal Health Insurance Portability and Accountability Act (HIPAA) requirements.

The Massachusetts Data Breach Notification Law requires businesses and organizations that own or license personal information to notify the Office of Consumer Affairs and Business Regulation and the Office of the Attorney General when they know or have reason to believe a breach of security has occurred. They must also notify the affected consumers whose information is at risk.

The notification must be made within a reasonable amount of time after the discovery of a breach or knowledge that personal information was obtained. The notification must include:

  • A detailed description of the nature and circumstances of the breach of security or unauthorized acquisition or use of personal information
  • The number of Massachusetts residents affected as of the time of notification
  • The steps already taken relative to the incident
  • Any subsequent steps intended to be taken relative to the incident
  • Information regarding whether law enforcement is investigating the incident

The breach may be the result of criminal cyber-activity, such as hacking or ransomware, or because of employee error, such as emailing information to the wrong person.

Personal information is defined as a resident's first name and last name or first initial and last name in combination with any one or more of the following:

  • Social Security number
  • Driver's license number or state-issued identification card number
  • Financial account number, or credit or debit card number, with or without any required security code, access code, personal identification number, or password, that would permit access to a resident's financial account

Notably, personal information does not include information that can be legally obtained from publicly available sources, such as addresses or birthdays.

In addition to the above, entities that are subject to HIPAA and report incidents following HIPAA standards must also meet the requirements of the Massachusetts data breach notification law. The HIPAA Breach Notification Rule requires healthcare organizations to report breaches that compromise the confidentiality, integrity, or availability of protected health information.

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Security risk assessments, gap identification, and remediation

In Massachusetts, the Health Insurance Portability and Accountability Act (HIPAA) is the primary legislation governing the protection of Protected Health Information (PHI). The HIPAA Security Rule requires covered entities and their business associates to conduct a risk assessment of their healthcare organization. This risk assessment helps to ensure compliance with HIPAA's administrative, physical, and technical safeguards. It also aids in identifying areas where PHI may be at risk. To facilitate this process, the Office of the National Coordinator for Health Information Technology (ONC) has developed a Security Risk Assessment (SRA) Tool, which is designed to guide small and medium-sized healthcare providers through the security risk assessment process.

When conducting a security risk assessment, it is important to identify gaps or weaknesses in the organization's security posture that could potentially expose PHI to unauthorized access or disclosure. This gap identification process involves a comprehensive review of the organization's security controls, policies, and procedures. By comparing the organization's current state with industry best practices and regulatory requirements, gaps or deficiencies can be identified.

Once gaps or vulnerabilities have been identified, it is crucial to prioritize and address them through remediation. Remediation involves implementing corrective measures to eliminate or mitigate the identified risks. This may include updating or enhancing security controls, policies, and procedures. It is important to ensure that remediation efforts are aligned with industry standards and regulatory requirements, such as those outlined in the HIPAA Security Rule.

The remediation process should be comprehensive and address all critical areas of security, including physical, administrative, and technical safeguards. This may involve implementing stronger access controls, enhancing data encryption, improving staff training and awareness, and establishing incident response plans. Additionally, regular security audits and penetration testing can help identify vulnerabilities and ensure the effectiveness of remediation efforts.

It is important to note that security risk assessments, gap identification, and remediation are iterative processes that should be continuously updated and improved. The healthcare organization should establish a culture of continuous monitoring and improvement to ensure the ongoing protection of PHI. By staying vigilant and proactive, organizations can effectively safeguard PHI and maintain compliance with applicable laws and regulations, including HIPAA.

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HIPAA policies and procedures

To ensure compliance with HIPAA Privacy, Security, and Breach Notification requirements, healthcare organizations in Massachusetts must implement written policies and procedures. These policies and procedures must be tailored to the specific needs of the practice and directly applicable to its operations. Annual reviews of policies and procedures are necessary to account for any changes in business practices, with amendments made as required.

To be HIPAA compliant, healthcare organizations must conduct six self-audits per year to identify security vulnerabilities and weaknesses. To meet HIPAA safeguard requirements, remediation plans must be created, listing identified deficiencies and the steps to address them, including actions and a timeline.

HIPAA also requires employee training, regardless of the state in which the healthcare organization operates. In Massachusetts, each employee with access to PHI must receive annual HIPAA training and legally attest that they understand and agree to adhere to the training material.

Business associate agreements must be signed with all business associate vendors. A business associate is defined by HIPAA as any entity that performs a service for the practice that gives them the potential to access PHI. Examples include electronic health records platforms, email service providers, online appointment scheduling software, and cloud storage providers. A business associate agreement (BAA) is a legal contract mandating that each signing party maintains HIPAA compliance and is responsible for their own compliance.

To comply with the HIPAA Breach Notification Rule, a system must be in place to detect, respond to, and report breaches. Employees must be able to report incidents anonymously and know what to do if they suspect a breach.

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Business associate agreements

In the US, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) sets out national standards for the protection of certain health information. The HIPAA Privacy Rule establishes a set of national standards for the use and disclosure of an individual's health information—called "protected health information" (PHI)—by covered entities.

A "business associate" is a person or entity that performs certain functions or activities that involve the use or disclosure of PHI on behalf of, or provides services to, a covered entity. A member of the covered entity's workforce is not a business associate. Common examples of business associates include electronic health records platforms, email service providers, online appointment scheduling software, and cloud storage providers.

In Massachusetts, business associate agreements must be signed with each business associate vendor. Healthcare providers cannot use any vendor and be HIPAA-compliant—the vendor needs to be willing and able to sign a BAA. When a vendor doesn’t sign a BAA, it cannot be used for business associate services.

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Massachusetts data breach notification law

In Massachusetts, the data breach notification law requires entities that own or license the personal information of residents to notify the Office of Consumer Affairs and Business Regulation and the Office of the Attorney General when a breach occurs. This must be done within a "reasonable amount of time" after the discovery of a breach or knowledge that personal information was obtained.

The notification must include:

  • A detailed description of the nature and circumstances of the breach.
  • The number of Massachusetts residents affected as of the time of notification.
  • The steps already taken in response to the incident.
  • Any subsequent steps intended to be taken relative to the incident.
  • Information regarding whether law enforcement is investigating the incident.

Additionally, entities must notify affected consumers whose information is at risk. This should be done even if the total number of affected residents is not yet known. The notification to consumers must include:

  • The consumer's right to obtain a police report.
  • Information on how to request a security freeze at no charge.
  • The name of the parent organization and any subsidiary organizations affected.
  • The nature of the breach or unauthorized acquisition or use.
  • The number of Massachusetts residents affected.
  • Contact information for the entity.

If ten or more patients cannot be reached by mail, a substitute notice must be made available on the entity's website. If 500 or more patients are affected, media outlets must also be notified to ensure that all affected individuals are aware of the incident.

Frequently asked questions

PHI stands for Protected Health Information. It includes all "individually identifiable health information", such as demographic data, and information relating to an individual's health condition, the provision of their health care, and the payment for the provision of their health care.

The HIPAA Privacy Rule establishes national standards to protect individuals' medical records and other individually identifiable health information (PHI). It gives individuals rights over their PHI, including the right to examine and obtain their health records, and sets limits and conditions on the use and disclosure of PHI without an individual's authorization.

There are different levels of severity for civil and criminal violations of HIPAA. Civil violations range from $100 to $50,000 per violation, with an annual maximum of $1.5 million. Criminal violations are handled by the DOJ and include fines of up to $250,000 and imprisonment of up to 10 years for the most severe offenses.

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