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Research in Massachusetts

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Massachusetts allows collected health information to be used for limited research purposes.  The Commissioner of Public Health can authorize the use of medical information for research purposes to reduce morbidity and mortality in the state of Massachusetts.1  De-identified, confidential birth information, fetal death information, and congenital abnormality information may be used for research purposes.2  

Additionally, the state authorizes the collection of data in registries to be used for research purposes.  All health care providers must report cases of cancer3 and congenital abnormalities4 to their respective registries.  Massachusetts law allows the disclosure of registry information for research purposes, but requires that patient identifying information not be used or released in studies.5

 

Footnotes

  • 1. M.G.L.A. 111 §24A
  • 2. 105 MA ADC 305.070; M.G.L.A. 111 §24B; M.G.L.A. 111 §202; M.G.L.A. 111 §67E
  • 3. 105 MA ADC 301.020
  • 4. 105 MA ADC 302.010
  • 5. M.G.L.A. 111 §111B; 105 MA ADC 301.040; 105 MA ADC 302.070

 

Research in Massachusetts

Subtopic Statute/Regulation Description
Publicly reported health information used for research (disease specific, registry data) (Cross reference Public Health Data Collection) 105. Mass. Code Regs. 301.015. - Information Required to be Reported Each cancer report submitted under 105 MA ADC 301.010 must include the following: Patient identifiers and demographics; Provider and facility...
105. Mass. Code Regs. 301.020. - Persons, Facilities, and Agencies Required to Report Information All health care facilities and providers must report cases of malignant disease and benign brain tumors diagnosed, treated, evaluated or medically...
105. Mass. Code Regs. 301.035. - Quality Assurance In order to assure the quality of the data submitted to the Cancer Registry, the health care facility and provider must allow the Cancer Registry to...
105. Mass. Code Regs. 302.050. - Medical Records Abstraction Abstractors must be qualified and trained to review and abstract medical records for the Congenital Abnormalities Registry.  Abstractors are...
Mass. Gen. Laws. Ann. ch. 111, §111B - Malignant disease and benign brain-related tumor registry; reports “Malignant disease and benign brain-related tumor registry; reports”   The department must establish a registry to record certain...
Use of publicly reported data for research purposes 105. Mass. Code Regs. 301.040. - Confidentiality of Reports The Department of Public Health must maintain the confidentiality of the reports sent to the Cancer Registry.  The Department cannot release any...
105. Mass. Code Regs. 302.010. - Information Required to be Reported Regarding Congenital Anomalies Physicians who make diagnoses prenatally, at birth or until 3 years, must be reported to the Commission and be placed in the Congenital Abnormalities...
105. Mass. Code Regs. 302.010. - Information Required to be Reported Regarding Congenital Anomalies “Information Required to be Reported Regarding Congenital Anomalies”   Directs the commissioner to require, as necessary and...
105. Mass. Code Regs. 302.070. - Confidentiality Information to be reported for the Congenital Abnormalities Registry must be necessary to conduct epidemiological studies and develop treatment and...
105. Mass. Code Regs. 305.070. - Application for Access to Confidential Birth Information for Research Purposes Confidential birth information may be used in the conduct of approved research including birth related medical and demographic data obtained pursuant...
Mass. Gen. Laws. Ann. ch. 111, § 67E - Children born with congenital anomaly, birth defect, birth injury or an intellectual disability; reports Within 30 days after diagnosis of a congenital abnormality, birth defect or birth injury that could lead to death or injury, the diagnosing physician...
Mass. Gen. Laws. Ann. ch. 111, §24M - Computerized immunization registry “Computerized immunization registry”   The Department must establish, maintain and operate a computerized immunization registry. The...
Mass. Gen. Laws. Ann. ch. 112, § 12R - Written statement of reasons for abortion; tests on pregnant patients prior to abortions; various reports – “Written statement of reasons for abortion as required by Sec. 12M; tests on pregnant patients prior to abortions; report to commissioner,...
Access to research information or data 105. Mass. Code Regs. 302.050. - Medical Records Abstraction Abstractors must be qualified and trained to review and abstract medical records for the Congenital Abnormalities Registry.  Abstractors are...
Confidentiality of research data (Cross reference Privacy & Confidentiality): Researchers may only disclose the minimum necessary to achieve research goals 105. Mass. Code Regs. 305.010. - Information Acquired for Administrative, Statistical or Research Purposes “Information Acquired for Administrative, Statistical or Research Purposes”   Confidential birth information contained in limited...
105. Mass. Code Regs. 305.050. - Permitted Disclosure of Confidential Birth Information Contained in Limited Data Sets “Permitted Disclosure of Confidential Birth Information Contained in Limited Data Sets”   The Department may disclose confidential...
105. Mass. Code Regs. 305.060. - Permitted Disclosure of De-identified Birth Information “Permitted Disclosure of De-identified Birth Information”   Authorizes the Department to release de-identified birth information to...
105. Mass. Code Regs. 305.065. - Permitted Disclosure of Aggregate Birth Information “Permitted Disclosure of Aggregate Birth Information”   AuthorizestheDepartment to disclose aggregate birth information for...
105. Mass. Code Regs. 305.080. - Restrictions on Use and Disclosure of Confidential Birth Information for Research Purposes “Restrictions on Use and Disclosure of Confidential Birth Information for Research Purposes”   Imposes restrictions on the use and...
Mass. Gen. Laws. Ann. ch. 111, §70G - Genetic information and reports protected as private information; prior written consent for genetic testing “Genetic information and reports protected as private information; prior written consent for genetic testing”   This section...
Confidentiality of research data (Cross reference Privacy & Confidentiality): Researchers prohibited from further disclosing information 105. Mass. Code Regs. 305.080. - Restrictions on Use and Disclosure of Confidential Birth Information for Research Purposes “Restrictions on Use and Disclosure of Confidential Birth Information for Research Purposes”   Imposes restrictions on the use and...
Mass. Gen. Laws. Ann. ch. 111, §70G - Genetic information and reports protected as private information; prior written consent for genetic testing “Genetic information and reports protected as private information; prior written consent for genetic testing”   This section...
Research Mass. Gen. Laws. Ann. ch. 111, § 111B - Malignant disease and benign brain-related tumor registry; reports The Department of Public Health must establish a registry to record cases of malignant disease and benign brain related tumors to conduct...
Mass. Gen. Laws. Ann. ch. 111, § 202 - Fetal deaths; reports; confidentiality; disposition of remains; violations; forms When a fetal death (defined as death occurring prior to extraction from mother, and does not breathe or show any evidence of life; it does not...
Mass. Gen. Laws. Ann. ch. 111, § 24A - Reduction of morbidity and mortality; establishment of program; information and reports The Commissioner of Public Health can authorize the use of medical information for research purposes to reduce morbidity and mortality within the...
Mass. Gen. Laws. Ann. ch. 111, § 24B - Birth information; statistical purposes Upon the birth of a child, the physician or nurse or person responsible for the birth must forward the relevant information to the Commissioner of...
Authorization needed for disclosure of information for research purposes (Cross reference Privacy & Confidentiality) Mass. Gen. Laws. Ann. ch. 111, §70G - Genetic information and reports protected as private information; prior written consent for genetic testing “Genetic information and reports protected as private information; prior written consent for genetic testing”   This section...
Click on the individual state law in the table above to see our summary of the individual law.


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