Ellen Janos

Ellen Janos

Mintz Levin

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Latest Posts › Healthcare


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 Healthcare Professionals 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

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In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”).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1/16/2015 - Draft Guidance FDA Healthcare Medical Devices mHealth Risk Assessment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

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