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Ellen L. Janos

Member

[email protected]

+1.617.348.1662

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Ellen utilizes her in-depth industry knowledge and decades of health law regulatory expertise to advise  providers, payers and companies doing business with, and investing in the health care space. She holds a Band 1 ranking in Chambers USA.  One of Ellen’s health care provider clients was quoted saying, “I can bring her any issue or question and she is able to quickly provide insights and answers that are practical and business-oriented. She is a true health care expert.”

Ellen is the founding member of Mintz’s multi-disciplinary, national Digital Health practice and provides strategic advice to traditional health care providers, investors, and start-ups on digital health initiatives including corporation formation, the evolving state and federal regulatory landscape. She advises clients on the legal issues involved in the use of health care data, HIPAA privacy and security matters and data breaches including investigations by the Office for Civil Rights.  Ellen previously served as a member of the advisory committee that worked with the Massachusetts Health IT Council on the development and implementation of the statewide HIT strategic plan and health information exchange.

Ellen also represents clients who are facing Medicare, Medicaid, and third-party payor audits and investigations and advises on the development of corporate compliance programs, hospital/physician relationships, and the state and federal anti-kickback laws and the Stark Law.  Before joining Mintz, Ellen served as  an assistant attorney general for the Commonwealth of Massachusetts for ten years where her work included representing state agencies responsible for health care reimbursement, licensing, and Medicaid fraud prosecutions. As an assistant attorney general, Ellen successfully argued two cases before the US Supreme Court.

Ellen writes about and speaks frequently on health care innovation, telehealth and telemedicine, the corporate practice of medicine and health care privacy and data security.   

Ellen utilizes her in-depth industry knowledge and decades of health law regulatory expertise to advise  providers, payers and companies doing business with, and investing in the health care space. She holds a Band 1 ranking in Chambers USA.  One of Ellen’s health care provider clients was quoted saying, “I can bring her any issue or question and she is able to quickly provide insights and answers that are practical and business-oriented. She is a true health care expert.”

Ellen is the founding member of Mintz’s multi-disciplinary, national Digital Health practice and provides strategic advice to traditional health care providers, investors, and start-ups on digital health initiatives including corporation formation, the evolving state and federal regulatory landscape. She advises clients on the legal issues involved in the use of health care data, HIPAA privacy and security matters and data breaches including investigations by the Office for Civil Rights.  Ellen previously served as a member of the advisory committee that worked with the Massachusetts Health IT Council on the development and implementation of the statewide HIT strategic plan and health information exchange.

Experience

  • Served as regulatory counsel to digital health clients including Folx Health, InStride Health, Marvin Behavioral Health and Hey Jane Re
  • Advised AmWell, a pioneer in telehealth technology and telemedicine services, in the development of its direct to consumer telemedicine platform
  • Represented CareWell Urgent Care in connection with its roll-out of urgent care centers in Massachusetts and joint venture models
  • Served as regulatory counsel to a behavioral health management company specializing in drug and alcohol treatment in connection with HIPAA and related privacy matters
  • Provided advice on state pharmacy laws relating to licensing, patient choice, mail order pharmacies, auto refill programs, and refills by mail and to a national nonprofit organization that provides reproductive health care
  • Advised a large hospital system on state corporate practice of medicine and professional entity laws in connection with it’s provision of cross border telemedicine services
  • Represented hospital clients in connection with internal peer review proceedings 
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viewpoints

Senate HELP Committee Signals Support for Permanently Expanding Telehealth Access

June 24, 2020 | Blog | By Cassandra Paolillo, Ellen Janos

Last week, the Senate Committee on Health, Education, Labor & Pensions (“Senate HELP”) held a hearing entitled “Telehealth: Lessons from the COVID-19 Pandemic," during which the Committee members expressed support for permanently expanding access to telehealth services. In this blog post, we discuss the Committee's proposals and the additional steps needed to permanently expand access to telehealth.
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In an interview yesterday, CMS administrator Seema Verma expressed support for permanently expanding access to telehealth services after the COVID-19 public health emergency resolves. Here, we explore the nature and duration of the temporary executive and regulatory orders, emergency legislation, and sub-regulatory guidance, which have resulted greater access to telehealth while leaving a fair amount of uncertainty as to what the future of telehealth looks like.
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Last week, the Centers for Medicare and Medicaid Services (CMS) announced additional waivers of limitations on Medicare reimbursement of telehealth services and updated its summary of COVID-19 blanket waivers. We’ve previously blogged about actions by CMS and other federal and state agencies to increase access to and encourage utilization of telehealth services during the COVID-19 pandemic through loosening of restrictions on telehealth reimbursement (see here and here). CMS is now taking additional steps to further these goals. Below is a summary of the major changes that CMS announced last week.
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As we’ve previously discussed on the blog, telehealth is playing a critical role in delivering care during the COVID-19 pandemic. Both Congress and states continue to take action to expand the use and reimbursement of telehealth services. The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed by Congress last Friday includes many provisions that further expand the use and reimbursement of telehealth during this public health emergency. Congress previously took action to start waiving certain telehealth requirements in the Coronavirus Preparedness and Response Supplemental Appropriations Act (Appropriations Act) passed on March 6, 2020, which we previously discussed here. In this post, we’ll cover the key ways that the CARES Act continues to remove barriers to telehealth, in addition to other recent federal and state actions.
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On Monday, FCC Chairman Ajit Pai circulated a plan to his fellow Commissioners detailing how the $200 million the agency will receive via the CARES Act should be deployed for a telehealth program to combat COVID-19.  The telehealth program will enable eligible healthcare providers to purchase telecommunications, broadband connectivity and information services, and devices necessary to provide telehealth services to beneficiaries.  The increased access to the tools needed to provide care via telehealth will allow COVID-19 patients to receive care and providers to give it, while reducing opportunities for further exposure.
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Telehealth is going to play a critical role in the delivery of care in the coming weeks and months as health care providers respond to the COVID-19 pandemic. As the CDC and other public health agencies continue to recommend social distancing and self-quarantine after exposure, telehealth is a vital tool for getting both sick and healthy individuals access to health care services they need if in-person services are not necessary. The use of telehealth services should help alleviate the ever-growing pressures on health care systems as they respond to the outbreak.  In light of these benefits, the Emergency Appropriations Bill passed by Congress last week includes provisions that allow the Secretary of Health and Human Services (HHS) to lift certain restrictions that are currently required for Medicare  reimbursement of telehealth services. 
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Telemedicine and the Coronavirus Outbreak

March 13, 2020 | Video | By Ellen Janos

Ellen Janos discusses the role telemedicine is expected to play in the management of the coronavirus outbreak as well as the Emergency Appropriations Bill passed Congress which contains provisions intended to loosen the restrictions on Medicare reimbursement for telehealth services.
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Artificial Intelligence is a growing part of our day-to-day life. And AI promises to improve our health care system. ML Strategies Vice President Christian Tomatsu Fjeld recently sat down with other experts for a panel discussion hosted by the San Francisco Business Times to discuss AI and some business and policy considerations across multiple industries. This viewpoint considers some of the impacts on health care specifically, and links out to the panel's discussion.
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A New Decade of HIPAA: What Can We Expect?

December 23, 2019 | Blog | By Dianne Bourque, Ellen Janos

As the decade winds down, it’s hard to believe that the HIPAA Privacy and Security Rules are almost twenty years old.  It has been ten years since the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published the first breach notification rule – the one based on the harm standard.   And the Omnibus Rule’s “low probability of compromise” standard is almost seven years old!   Regulators and regulated entities are heading into the new year and decade with a lot of momentum on some important issues.  As we prepare to welcome 2020, we’d like to indulge in a bit of hindsight – as well as speculation – about what the new decade might hold for HIPAA-regulated entities. 
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Practice Intro Health Care Enforcement Investigations Mintz
On August 8, 2019, FDA issued a notice on its medical device recall database that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered directly to consumers. This represents a recent example of FDA taking enforcement action against a telemedicine software company that ultimately resulted in removal of the app from commercial distribution.
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News & Press

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Mintz is pleased to announce that 120 firm attorneys have been recognized as leaders by Best Lawyers® in the 2024 edition of The Best Lawyers in America©.
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BOSTON –Mintz announced today that 39 of its practices and 81 of its attorneys earned recognition in the 2023 edition of Chambers USA, a guide to the country’s leading law firms.
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BOSTON – Mintz has launched a Women’s Health and Technology practice, bringing together attorneys from across the firm’s transactional, intellectual property, health care and FDA regulatory, and litigation teams with a focus on serving clients in life sciences, specifically FemTech.
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Law360 featured the launch of the firm's Women's Health and Technology practice and highlighted founding Members Ellen Janos, Joanne Hawana, Karen Lovitch, and Melanie Levy.
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35 Mintz attorneys have been named Massachusetts Super Lawyers and 25 Mintz attorneys have been named Massachusetts Rising Stars for 2022.
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Firm provides pro bono legal counsel to global health nonprofit on groundbreaking initiative to slow the spread of COVID-19 in the Commonwealth of Massachusetts.
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This feature article discusses how artificial intelligence solutions could be used to help answer beneficiary questions, review claims. Ellen Janos, a Member and experienced health care regulatory attorney, provides commentary within the piece.
This feature story discusses the rise in use of mobile therapy apps as suicide rates increase. The regulatory concerns and issues associated with these apps are highlighted within the piece and Health Law Member Ellen Janos is quoted providing commentary.
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Mintz partner and Massachusetts lawyer Julie Korostoff is one of 49 attorneys recognized as “Leaders in Their Fields” by the 2018 Chambers USA: America's Leading Lawyers for Business guide. Chambers named Korostoff a “Recognized Practitioner” in Technology.
This feature article discusses a Medicare proposal to expand patient access to medical records. The piece notes that while the proposal could help to streamline the use of electronic health records, it could prove to be burdensome to health care providers.
This feature story notes concerns in regards to the potential hacking of all the data being collected by makers of personal health care devices. Mintz Health Law Member Ellen Janos is among the industry sources providing commentary within the piece.
Health Law Member Ellen Janos provides commentary in this feature article discussing the recommendations of a recent Government Accountability Office report noting the need for increased data security oversight by the Centers for Medicare & Medicaid Services.
Mintz Member and health care attorney Ellen Janos is quoted in this article, which notes that Medicare plans will make sharing patient records easier. Ellen is among those sources quoted discussing the potential impact of the plan which would give patients more control over their medical data.
Ellen Janos, a Member in Mintz’s health law practice, quoted in Bloomberg BNA regarding the upcoming information blocking ruling and whether or not it will curb the blocking of the exchange of health data.
Ellen Janos is a Member in the Health Law Practice at Mintz. The government issued a draft of the Trusted Exchange Framework, released on January 5th, encouraging health-data networks to link up and provide access to each other.
Member Ellen Janos is a health law and health care enforcement defense attorney. She authored a column for Law360 column on the topic of digital health. Ellen points out some questions to consider when assessing a digital health service or product.
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Best Lawyers named 85 Mintz attorneys to its 2018 list of The Best Lawyers in America. In addition, Mintz attorneys Matthew J. Gardella and Samuel M. Tony Starr were named “Lawyer of the Year” in their respective practice areas.
Fifty-three Mintz attorneys have been named Massachusetts Super Lawyers for 2016 and thirty-one have been named Massachusetts Rising Stars. The findings will be published in the November 2016 issue of Boston Magazine and in a stand-alone magazine, New England Super Lawyers. 
Best Lawyers named 73 Mintz attorneys to its 2017 list of The Best Lawyers in America. Mintz attorneys selected for inclusion in this year’s list span 44 practice areas. 
Firm’s National Healthcare Practice, NY Corporate/M&A and Litigation: General Commercial Among Newest Rankings
The 2015 Chambers USA: America's Leading Lawyers for Business guide names 52 Mintz, Cohn, Ferris, Glovsky and Popeo, P.C.  attorneys as “Leaders in Their Fields.”
Julie Korostoff, Co-chair of Mintz’s IT Transactions & Outsourcing Practice, and Mintz partner Ellen Janos are participating in a panel on “Operating a Successful Telemedicine Program” at the 2015 American Telemedicine Association Annual International Meeting & Trade Show.
Mintz partner Julie Korostoff is giving a presentation on "IT Contracting for Telemedicine” and participating with Mintz Partner Ellen Janos in a panel on legal and contract issues facing telemedicine programs at the 2014 American Telemedicine Association Annual International Meeting & Trade Show.
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Events & Speaking

Moderator
Panelist
Mar
10
2021

Healthcare Law & Compliance Institute

International Performance Management Institute

Virtual Event

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Moderator
Dec
1
2020

Telehealth: What's Next?

Women Business Leaders of the U.S. Health Care Industry Foundation (WBL) Event

Online Event

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Speaker
May
13
2019

Regulatory and Business Strategies for MedTech and Telehealth

Effective Business Planning: Additional Regulatory and Policy Challenges

Wiley Rein LLP, 1776 K Street, NW

Speaker
Panelist
Dec
13
2018

HFMA Annual Compliance Update

Compliance Roles and Responsibilities in Relation to Disruptive Technology

Offices of Deloitte & Touche, 200 Berkley Street, Boston, MA

Panelist
Jun
13
2018

American Well’s Client Forum 2018

American Well

Boston, MA

Speaker
Panelist
Jun
22
2016

The Promise of Telemedicine

Massachusetts Hospital Association

Boston, MA

Panelist
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Ellen utilizes her in-depth industry knowledge and decades of health law regulatory expertise to advise  providers, payers and companies doing business with, and investing in the health care space. She holds a Band 1 ranking in Chambers USA.  One of Ellen’s health care provider clients was quoted saying, “I can bring her any issue or question and she is able to quickly provide insights and answers that are practical and business-oriented. She is a true health care expert.”

Ellen is the founding member of Mintz’s multi-disciplinary, national Digital Health practice and provides strategic advice to traditional health care providers, investors, and start-ups on digital health initiatives including corporation formation, the evolving state and federal regulatory landscape. She advises clients on the legal issues involved in the use of health care data, HIPAA privacy and security matters and data breaches including investigations by the Office for Civil Rights.  Ellen previously served as a member of the advisory committee that worked with the Massachusetts Health IT Council on the development and implementation of the statewide HIT strategic plan and health information exchange.

Recognition & Awards

  • Chambers USA: Massachusetts – Healthcare (2008 – 2020); (Band 1) - Healthcare (2021 – 2023) 

  • Best Lawyers in America: Health Care Law (2008 – 2024)

  • Included on the Massachusetts Super Lawyers: Health Care list (2004 – 2018, 2021-2022)

  • Best Lawyers in America: Boston Health Care Law Lawyer of the Year (2014)

  • Recognized by The Legal 500 United States for Healthcare: Service Providers (2014 – 2015)

  • Heroes of the Field Award 2010, Massachusetts Medical Law Report

  • Martindale-Hubbell AV Preeminent

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Ellen utilizes her in-depth industry knowledge and decades of health law regulatory expertise to advise  providers, payers and companies doing business with, and investing in the health care space. She holds a Band 1 ranking in Chambers USA.  One of Ellen’s health care provider clients was quoted saying, “I can bring her any issue or question and she is able to quickly provide insights and answers that are practical and business-oriented. She is a true health care expert.”

Ellen is the founding member of Mintz’s multi-disciplinary, national Digital Health practice and provides strategic advice to traditional health care providers, investors, and start-ups on digital health initiatives including corporation formation, the evolving state and federal regulatory landscape. She advises clients on the legal issues involved in the use of health care data, HIPAA privacy and security matters and data breaches including investigations by the Office for Civil Rights.  Ellen previously served as a member of the advisory committee that worked with the Massachusetts Health IT Council on the development and implementation of the statewide HIT strategic plan and health information exchange.

Involvement

  • • Member, Board of Directors, North End Waterfront Health
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