Purpose of the registry
In 2002, Massachusetts was one of 7 states awarded funds by the U.S. Centers for Disease Control and Prevention to track health conditions thought to be impacted by the environment. The statewide registry, initially supported by these funds, was established in 2003 under legislation supported by ALS patients and advocacy groups calling for more research into the causes of ALS.
We use the ALS Registry to determine the prevalence of disease and the frequency of new cases in MA. This information allows DPH to compare state rates to those found in other places, to check trends over time, and to identify the geographic patterns of ALS across the state. Additionally, a registry can help public health and other researchers investigate causes of ALS and advance research for treatments.
MA ALS Registry vs. the National ALS Registry
The National ALS Registry is a separate and voluntary registry created to identify and gather information about ALS from cases throughout the United States. Unlike the MA ALS Registry, which automatically registers all ALS cases who are residents of Massachusetts as a result of the required physician reporting, persons with ALS must register to become a part of the National ALS Registry. While the two are not directly associated, both provide important and unique opportunities to add to the current knowledge of ALS occurrence. We encourage patients to register through the National ALS Registry website and to speak to their physician to confirm the required reporting of ALS in Massachusetts if they wish to ensure reporting of their case.
Public and medical community involvement
DPH ALS Registry staff worked closely with an ALS advisory committee during the development process. The committee was comprised of health care providers, state legislators, patients, and their families. The committee has continued to meet periodically to discuss the progress of the Registry to ensure the best interests of the ALS community are met.
ALS Registry data and confidentiality
Patient information contained in the Registry
The Registry contains data on:
- Patient demographics (age, gender, address)
- Clinical symptoms and laboratory data
- Diagnosis
- Treatment
This is confidential information. The U.S. Health Insurance Portability and Accountability Act (HIPAA) allows physicians to report to DPH for the purpose of disease surveillance.
All private health information collected by DPH, including patient names, addresses, and medical records, is kept confidential and is protected by law. Confidential patient information may only be shared with researchers with approval of the DPH Institutional Review Board (IRB), which reviews study proposals for scientific merit and requires strict provisions to protect patient confidentiality. In such instances, DPH may share the minimally necessary information to meet the specific research purposes and only under strict IRB guidelines. Requests that receive IRB approval may also require researchers to first get a patient’s informed consent.
Will researchers be able to contact people identified in the Massachusetts Registry?
Researchers must apply for access to Registry data through the DPH Institutional Review Board. To be approved, studies must be able to guarantee the continuous protection of patient confidentiality. If a researcher requires contact with patients to complete a study, they must go through a rigorous approval process through the DPH IRB in order to contact patients to obtain informed consent. This type of research can help patients enroll in clinical trials and epidemiological research studies related to the causes of or treatments of ALS.
Publicizing and distributing ALS information from the Registry
DPH will prepare reports containing community-specific and statewide prevalence and incidence estimates, as well as any trends occurring over time and across the state. No person will be identified or identifiable in any public documents. All Registry-related documents are available on the Bureau of Climate and Environmental Health website. Data from the Registry will also be available in late 2018 on the Environmental Public Health Tracking website.
ALS as a reportable disease
ALS is considered a reportable disease under Title 105 of the Code of Massachusetts Regulations (CMR), Section 300.192: “Surveillance of Diseases Possibly Linked to Environmental Exposures.” The Massachusetts Department of Public Health is authorized to collect medical records and other identifiable information from health care providers and other persons subject to 105 CMR 300.000, and/or prepare data, as detailed in 105 CMR 300.190 and 300.191, on people evaluated for or diagnosed with ALS and other selected environmental related diseases.
Under Massachusetts General Law (MGL) Title 111, Section 24A, all information collected for public health investigations approved by the Commissioner of Public Health is strictly confidential and is not admissible as evidence in any legal proceeding. The statute also states that anyone providing information to a researcher approved by the Commissioner of Public Health shall not be liable for any damages related to that disclosure.