Some very good news for the telehealth community can be found amidst the more than 1,400 pages of the proposed Medicare Physician Fee Schedule for 2019 (“Proposed Rule”) issued by CMS yesterday. Finally, CMS acknowledges just...more
As we look back on 2017, one message is clear: don’t be a Scrooge when it comes to HIPAA compliance. With ever-evolving security threats and unrelenting enforcement, regulated entities must maintain a spirit of compliance...more
The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more
10/11/2017
/ Algorithms ,
Carbon Monoxide Exposure ,
Endorsements ,
Enforcement Actions ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Mobile Health Apps ,
Settlement Agreements ,
Substance Abuse ,
Unfair or Deceptive Trade Practices
The U.S. Department of Veterans Affairs (“VA”) is taking a significant step towards expanding needed services to Veterans by proposing a rule to preempt state restrictions on telehealth....more
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more
9/18/2017
/ App Developers ,
COPPA ,
Cybersecurity ,
Data Privacy ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Intellectual Property Protection ,
IP License ,
Medical Devices ,
Mobile Health Apps ,
Mobile Medical Applications ,
Software ,
Unfair or Deceptive Trade Practices
Last week, the Massachusetts Department of Public Health issued another round of proposed amendments to its regulations, continuing the Baker Administration’s regulatory reform efforts. Today, we take a closer look at the...more
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
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
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
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 ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Fraud ,
Home Health Care ,
Individual Accountability ,
Kickbacks ,
Marketing ,
Medical Records ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Physicians ,
Sales ,
Training ,
Unauthorized Access ,
Vendors ,
Warner Chilcott
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
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 ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
EHR ,
Electronic Health Record Incentives ,
Electronic Medical Records ,
GAO ,
Health Care Providers ,
Healthcare ,
HITECH Act ,
Meaningful Use ,
Medicaid ,
Medicare ,
Medicare Access and CHIP Reauthorization (MACRA) ,
Medicare Part B ,
PQRS ,
Telehealth ,
Telemedicine
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
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
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
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
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
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
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
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
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
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