Tag Archives: Mobile Devices

Pharmaceutical Digital Health Innovators Take Note: FDA Public Hearing on an Innovative Approach to Devices Referencing Drugs

On November 16, 2017, the Food and Drug Administration (“FDA” or the “Agency”) will hold a public hearing on a proposed approach for sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device. FDA will accept comments to the docket until January … Continue Reading

FDA Releases Details and Timelines in Its Digital Health Innovation Action Plan

On July 27, FDA published its Digital Health Innovation Action Plan. The plan provides details and timelines for the agency’s Digital Health Innovation Plan, announced by FDA Commissioner Scott Gottlieb last month. The action plan describes the agency’s “next steps” over the coming year to “encourage digital health innovation by redesigning [FDA’s] policies and processes … Continue Reading

ICO Rules UK Hospital-DeepMind Trial Failed to Comply with UK Data Protection Law

The UK Information Commissioner’s Office (“ICO”), which enforces data protection legislation in the UK, has ruled that the NHS Royal Free Foundation Trust (“Royal Free”), which manages a London hospital, failed to comply with the UK Data Protection Act 1998 in providing 1.6 million patient records to Google DeepMind (“DeepMind”), requiring the Royal Free to sign an … Continue Reading

Comments Requested on Draft Guide on Securing Electronic Health Records on Mobile Devices

The National Cybersecurity Center of Excellence (“NCCoE”) has released a draft for public comment of the first guide in a new series of publications “that will show businesses and other organizations how to improve their cybersecurity using standards-based, commercially available or open-source tools.” The guide discusses how to secure electronic health records on mobile devices. … Continue Reading

JP Morgan Conference Highlights eHealth Technologies, Data-Driven Therapeutics

The excitement around eHealth innovations was palpable throughout San Francisco this week as the annual JP Morgan healthcare conference flooded the city.  JP Morgan itself offered panels and presentations from industry leaders and emerging companies, while simultaneously occurring conferences, speaker programs, and networking events throughout San Francisco featured discussions on the changing face of healthcare … Continue Reading

FTC Remarks Signal Heightened Focus on Mobile Health Devices

Federal Trade Commission (FTC) chairwoman Edith Ramirez’s remarks at the International Consumer Electronics Show on Tuesday signal that FTC may be paying increased attention to privacy and security issues in the mobile health industry. The speech focused on how “the introduction of sensors and devices into currently intimate spaces – like our homes, cars, and … Continue Reading

Members of Congress Ask for Clarity on HIPAA and Mobile Devices

Last month, two Members of Congress wrote to Secretary Burwell of the U.S. Department of Health and Human Services, urging the agency to adopt new guidance on HIPAA compliance for mobile devices. In their letter, Representatives Tom Marino (R-PA) and Peter DeFazio (D-OR) note that much of HHS’s current guidance predates the proliferation of mobile … Continue Reading
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