Ellen Janos

Ellen Janos

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Telemedicine Platform Recalled Over Failure to Obtain Pre-Market Clearance or Approval from FDA

On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more

8/30/2019  /  Enforcement Actions , FDA Warning Letters , Food and Drug Administration (FDA) , Health Care Providers , Medical Devices , Medical Software , Mobile Medical Applications , Product Recalls , Regulatory Oversight , Telemedicine

Building a Health App? Part 4: Avoiding an FTC Enforcement Action

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

Building a Health App? What You Need to Know

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

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In another effort to bring some clarity to its regulation of devices, the FDA has released draft guidance on how its risk-based framework applies to accessory devices ( the “Draft Guidance”).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1/16/2015  /  Draft Guidance , Food and Drug Administration (FDA) , Healthcare , Medical Devices , mHealth , Risk Assessment

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 , FDASIA , Food and Drug Administration (FDA) , 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  /  Food and Drug Administration (FDA) , Healthcare , Medical Devices , Prescription Drugs , TRICARE
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