Ellen Janos

Ellen Janos

Mintz Levin

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Latest Publications


Massachusetts Licensure of Clinics Proposed Regulations – Key Take-Aways

In previous blog posts, we addressed the Massachusetts Department of Public Health’s (DPH) proposed regulations that affect hospitals, dialysis clinics and medical marijuana programs. In this final post on DPH’s recent...more

10/19/2016 - Comment Period Health Care Providers Hospitals License Renewals Proposed Amendments Proposed Regulation Public Health Transfer of Title Urgent Care Facilities

U.S. Department of Defense Expands Telemedicine Access for Military Members

Last month, Jonathan Woodson, M.D., the Assistant Secretary of Defense for Health Affairs for the U.S. Department of Defense, issued a memorandum that effectively changes the Military Health System (“MHS”) policy on...more

3/9/2016 - Department of Defense (DOD) Military Service Members Telemedicine

Telemedicine – 2015 Year in Review

As the year winds down, we look back on the significant developments in telemedicine in 2015 as well as look forward to what 2016 will bring. The number of providers offering telemedicine and telehealth services dramatically...more

12/24/2015 - Healthcare Medical License Medicare Telehealth Telemedicine

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more

11/5/2015 - Civil Liability Conspiracies Criminal Liability Disclosure Durable Medical Equipment Guilty Pleas Health Care Providers Healthcare Fraud HIPAA Home Health Care Individual Accountability Kickbacks Marketing Medical Records Patient Privacy Rights Pharmaceutical Industry Physicians Sales Training Unauthorized Access Vendors Warner Chilcott

Massachusetts Health Care Regulatory Review – Opportunity for Industry Comment

Health care is big business in Massachusetts, and it is a highly regulated business. But Governor Charlie Baker hopes to simplify the Massachusetts regulatory regime. This past March, Governor Baker initiated a year-long...more

6/26/2015 - Health Care Providers Healthcare Regulatory Agenda

MACRA’s Advancement of EHR Interoperability and Telehealth

This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10. We’ve previously covered the repeal of the Sustainable Growth Rate (SGR) in our April 20th post,...more

4/27/2015 - Affordable Care Act CMS EHR Electronic Health Record Incentives Electronic Medical Records GAO Health Care Providers Healthcare HHS HITECH Meaningful Use Medicaid Medicare Medicare Access and CHIP Reauthorization (MACRA) Medicare Part B PQRS Telehealth Telemedicine

Proposed Replacement of Sustainable Growth Rate Addresses Telehealth

On March 19th, Representative Michael C. Burgess, M.D. (R-TX) and Senate Finance Committee Chairman Orrin Hatch (R-UT) unveiled a bipartisan plan to repeal and replace the sustainable growth rate (SGR) physician payment...more

3/23/2015 - ACOs Healthcare Legislative Agendas Next Generation ACO (NGACO) Physician SGR Formula Physicians Telehealth

Telehealth Bill Moving Forward in Florida-But Medicaid Coverage Sacrificed

Last week, the Florida Senate Health Policy Committee removed language from proposed telehealth legislation that would require Medicaid reimbursement for telemedicine services at the same rates as face-to-face examinations....more

2/25/2015 - Health Care Providers Medicaid Medical Reimbursement mHealth Physicians Telehealth Telemedicine

FDA Proposes to Apply Risk-Based Framework to Accessory Devices

In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”). This development is welcome...more

1/16/2015 - Draft Guidance FDA Healthcare Medical Devices mHealth Risk Assessment

Registration Begins for American Telemedicine Association’s New Accreditation of Online Medical Services

The American Telemedicine Association (ATA) is now accepting limited registrations for organizations that wish to gain ATA’s seal of approval for online medical services. Registration for the new Accreditation Program for...more

12/19/2014 - Accreditation Healthcare Registration Telemedicine

Continuing a Growing Trend, Telemedicine Efforts Move Forward

Last week, the American Telemedicine Association (ATA) approved its new telepathology guidelines, which provide updated guidance on specific applications, practices, benefits, limitations, and regulatory issues that may arise...more

8/15/2014 - Healthcare Telemedicine

Regulation of Health IT: A Risk-Based Approach

The FDA will hold a public workshop on May 13-15, 2014 to discuss the long-awaited report (the “Report”) issued on April 3, 2014 by the three federal agencies charged with regulating health information technology (“health...more

5/8/2014 - FCC FDA FDASIA Healthcare ONC Technology

Tri-Agency Health IT Report Issued

Today, the three federal agencies charged with regulating components of health information technology (“Health IT”) issued their long-awaited Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework...more

4/4/2014 - FDA Healthcare Medical Devices Prescription Drugs TRICARE

Record Attendance at American Telemedicine Association Annual Meeting

The American Telemedicine Association (ATA) wrapped up its 2013 Annual Meeting in Austin, Texas on Monday. Over 5,000 people attended the ATA’s largest annual meeting ever. The extraordinary advances in technology over the...more

5/10/2013 - Healthcare Telemedicine

Congressional Representative Signals Willingness to Facilitate Telehealth Services

In opening remarks at the Health Information Technology hearing series last week, Representative Doris Matsui (D-CA), a member of the Energy and Commerce Committee, indicated that she intends to introduce legislation that...more

3/27/2013 - Healthcare Telehealth

HIPAA Omnibus Rule Reference Chart

Mintz Levin is pleased to provide this section-by-section analysis of the HIPAA Omnibus Rule. The chart lists provisions of the proposed privacy, security and enforcement rules mandated by the Health Information...more

1/23/2013 - Business Associates Covered Entities Data Breach Data Protection HIPAA HIPAA Omnibus Rule HITECH Notice Requirements PHI

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