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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 is a terrific adviser; she is very knowledgeable and practical.

- Health Care Client, Chambers USA 2024

Ellen is an excellent litigator with great advocacy and client skills.

- Health Care Client, Chambers USA 2024

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

The indictment, arrest, and arraignment of Ruthia He, the founder, CEO, and clinical president of Done Global (Done), and David Brody, clinical president of Done and the sole shareholder of Done Health, P.C. (PC) in connection with their alleged criminal conspiracy to distribute controlled substances, commit health care fraud, and obstruct justice may bring heightened scrutiny to behavioral health telemedicine companies and other virtual health platforms. The seven-count indictment represents the Department of Justice’s (DOJ’s) first criminal drug distribution prosecutions related to telemedicine prescribing. The prosecution of the defendants is proceeding in federal court in the Northern District of California and several additional Done personnel including an executive, physician, and nurse practitioners are similarly being prosecuted.

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As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and the celebration of numerous milestones.

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As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the regulatory environment with modern health care delivery, cutting-edge technologies, and innovative data-sharing techniques. Some of this work has been done in the form of federal agency guidance in which health care organizations will be looking for additional updates and there are also a handful of pending U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) proposals that call for substantial changes to the HIPAA Privacy Rule.

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As we previously covered, in March 2023, the Drug Enforcement Agency (DEA) announced a proposed rule on prescribing controlled substances via telehealth, aimed at addressing the “telehealth cliff” that was expected to occur once the COVID-19 Public Health Emergency (PHE) ends on May 11, 2023. The proposed rule provided some flexibility, but required a much more restrictive framework for prescribing controlled substances via telehealth compared to the flexibilities available during the PHE. During the 30-day comment period following the announcement of the proposed rule, the DEA received over 38,000 comments, which the agency says it is closely reviewing. Many commentators across the health care industry criticized the proposed rule because the in-person examination requirement would limit access to care. The DEA, working with the Department of Health and Human Services, is also considering revisions to the proposed rule. 

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With just over two months before the COVID-19 Public Health Emergency (PHE) expected expiration on May 11, 2023, the Drug Enforcement Agency (DEA) has finally announced its proposed rule on prescribing controlled substances via telehealth. This post provides continued coverage of telehealth updates and dissects what this DEA's proposed rule could entail. 

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The COVID-19 Public Health Emergency (PHE), which was originally declared nearly three years ago, has been renewed through April 2023. As we’ve previously covered, the PHE allowed federal and state regulators to relax certain telehealth requirements, which has led to a rapid expansion in the availability of telehealth services. The Biden Administration has committed to provide at least 60 days’ notice prior to terminating the PHE or allowing it to expire, but several news outlets are reporting that this could be the final extension. 

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Many of the flexibilities upon which telehealth providers have come to rely in recent years are tied to the federal Public Health Emergency related to the COVID-19 pandemic (PHE). As we move into Fall 2022, we review the current state of the PHE flexibilities around Medicare reimbursement and prescription of controlled substances, examine pending legislation that, if passed, would bring greater certainty to patients and providers, and discuss what we know about the status of a possible PHE extension.

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As we’ve previously covered, while Congress has acted to extend certain COVID-era telehealth flexibilities (mostly related to Medicare coverage) beyond the Public Health Emergency (PHE), the future of prescribing controlled substances via telehealth is uncertain.  Although the American Telemedicine Association and other industry groups continue to advocate for changes to allow telehealth providers to prescribe controlled substances in certain circumstances, without further action by Congress or the Drug Enforcement Administration (DEA), telehealth providers who prescribe controlled substances will need to conduct an in-person examination of the patient once the PHE ends. 

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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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Mintz’s new Women’s Health and Technology Practice brings together attorneys from our transactional, intellectual property, health care, FDA regulatory, and litigation teams to serve FemTech and other life sciences clients. The practice advises companies, entrepreneurs, and investors focused on addressing unmet needs in women’s health.

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Law360 featured the launch of the firm's Women's Health and Technology practice and highlighted founding Members Ellen JanosJoanne HawanaKaren 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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Best Lawyers® recognized 108 firm attorneys in the 2023 edition of The Best Lawyers in America©. Notably, two Mintz attorneys – Poonam Patidar and Scott M. Stanton – received 2023 “Lawyer of the Year” awards, and 28 firm attorneys were included in the inaugural edition of Best Lawyers: Ones to Watch.

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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 – 2024) 

  • 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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