Mass HIway Proposed Regulation Summary

November 7, 2016
the Massachusetts Executive Office of Health & Human Services (EOHHS)


The Massachusetts Executive Office of Health & Human Services (EOHHS) has announced that proposed Mass HIway Regulations are open for public comment.

  • The public comment period is scheduled for November 4th-29th, 2016 
  • A public hearing is scheduled for November 28th, 2016
  • The goal is to promulgate regulations by late January 2017

To access the full regulations proposed, instructions on how to submit comments, and information about the public hearing, visit:

About the Regulations:

Regulations apply to key requirements of Massachusetts General Law (M.G.L.) Chapter 118I:
1) The requirement for all providers to implement a fully interoperable electronic health record (EHR) that connects to the Mass HIway, the statewide health information exchange (HIE); and
2) The establishment of a mechanism to allow patients to opt-in and opt-out of the Mass HIway.
To help ensure that regulations were developed through an open, transparent process, EOHHS gathered feedback from multi-stakeholder advisory groups and presented proposals for discussion at the publicly held meetings with the Health Information Technology Council.

What is the Mass HIway?

The Mass HIway is the Massachusetts statewide Health Information Exchange operated by EOHHS. The Mass HIway has two main functions:

  • Function #1 – HIway Direct Messaging: The Mass HIway offers a secure method for Mass HIway Users (which includes Provider Organizations and other organizations that are approved by the Mass HIway) to transmit a message with information about a patient to other users, where the Mass HIway does not analyze, use, or share the contents of the message except as required to deliver it and to make it available for use by the intended recipient.
  • Function #2 – HIway-Sponsored Services: The Mass HIway plans to offer services that can aid providers in health care coordination including the forthcoming state-wide Event Notification Service (ENS), which will enable notifications to be sent to a patient's health care providers when that patient is admitted to any participating hospital in the state. Mass HIway will use and disclose limited information about patients as required to provide these services.

Who must connect to the Mass HIway, and when?

Proposed regulations require specified Provider Organizations to connect to the Mass HIway, rather than individual providers who hold a professional license in the state.

Proposed regulations are based on a phased-in approach, with acute care hospitals, medical ambulatory practices with 10 or more licensed providers participating in healthcare delivery, and all community health centers being required to connect to the Mass HIway between 2017 and 2019, while all other types of Provider Organizations (e.g., behavioral health entities, dental clinics, and nursing homes) will be required to connect at a date that will be specified in the future with at least a 1 year notice, and will be no earlier than January 2018. These connection requirements will be established through future regulations.

How must Provider Organizations connect to the Mass HIway?

Proposed regulations require Provider Organizations to attest to implementing at least one Use Case of HIway Direct Messaging. Example Use Cases include a hospital using the Mass HIway to send discharge summaries to a skilled nursing facility, or a primary care physician practice using the Mass HIway to send referrals to a specialty practice.

Proposed regulations require acute care hospitals to send Admission, Discharge, and Transfer (ADT) messages to the Mass HIway to support the forthcoming state-wide ENS within 12 months after the launch of the ENS.

HIway Direct Messaging

Mass HIway users may transmit information via HIway Direct Messaging in compliance with applicable federal and state privacy laws (e.g., HIPAA, 42 CFR Part 2, M.G.L Chapter 93H) and implementing regulations. Such requirements would align use of HIway Direct Messaging with other modes of transmission, such as sending a fax or making a phone call. Mass HIway users may implement a local opt-in and/or opt-out process that applies to the use of HIway Direct Messaging by their organization, but are not required to do so.

HIway-Sponsored Services

  • The opt-in mechanism for HIway-Sponsored Services will be fulfilled by HIway Participants informing patients through written notice that the HIway Participant intends to use HIway-Sponsored Services. The written notice must describe how the patient can opt-out.
  • The Mass HIway or its designee will administer a centralized opt-out system for HIway-Sponsored Services. A HIway participant that has an established relationship with a patient must: (a) notify the Mass HIway if a patient decides to opt-out, and/or (b) provide written instructions to a patient on how they or their authorized designee can notify the Mass HIway or its designee of their choice to opt-out.
  • HIway Participants may choose to implement additional local opt-in/opt-out processes that would apply to their organization as supplemental processes, not replacements, of these provisions.

What are the requirements regarding Electronic Health Records (EHRs)?

Proposed regulations state that the requirement to implement a fully interoperable EHR that connects to the Mass HIway will be met by Provider Organizations meeting the requirements for HIway Direct Messaging. “Fully interoperable” will be defined as the ability to send and receive HIway Direct Messages. (Click here for technology requirements for sending a Direct Message over the Mass HIway).

Proposed regulations state that Provider Organizations with required dates for connecting to the Mass HIway will be required to submit information regarding their EHR to the Mass HIway by their first required connection date.

What other guidance will be provided in the Mass HIway regulations?

Proposed regulations establish penalties for not connecting to the Mass HIway, describe a waiver process for Provider Organizations that are unable to fulfill the connection requirements outlined in the regulations, set fees associated with the use of the Mass HIway, and create an appeals process related to penalty determinations made by EOHHS.

Notice of Important Changes to the Mass HIway Policies and Procedures:

The Mass HIway Policies & Procedures (version 2 available here) is also being updated to align with these regulations, to streamline Mass HIway documentation and contracts, and to update procedures and practices to reflect changes in the healthcare information technology environment. A draft updated Mass HIway Policies & Procedures is expected to be available late 2016.

Download the Mass HIway Regulations Summary PDF