Mobile Devices

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

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 undertaking committing to changes to ensure it is acting in line with the UK Data Protection Act.

On September 30,  2015, the Royal Free entered into an agreement with Google UK Limited (an affiliate of DeepMind) under which DeepMind would process approximately 1.6 million partial patient records, containing identifiable information on persons who had presented for treatment in the previous five years together with data from the Royal Free’s existing electronic records system.  On November 18, 2015, DeepMind began processing patient records for clinical safety testing of a newly-developed platform to monitor and detect acute kidney injury, formalized into a mobile app called ‘Streams’.
Continue Reading ICO Rules UK Hospital-DeepMind Trial Failed to Comply with UK Data Protection Law

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. “The draft guide was developed by industry and academic cybersecurity experts, with the input of health care providers who first identified the challenge.”
Continue Reading Comments Requested on Draft Guide on Securing Electronic Health Records on Mobile Devices

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 in today’s world of increasing digitization, economic transformation and regulatory oversight.

Major deal announcements were also triggered by the “Superbowl of Healthcare” buzz this week, including scores of new eHealth initiatives and start-ups.  We’ve highlighted a few of the big deals of the week below.

Complex Cross-Disciplinary Approaches: Roche and Foundation Medicine Announce New Partnership

In an approximately $1.2 billion deal, Roche agreed to acquire a majority stake in cancer diagnostic maker Foundation Medicine.  The companies simultaneously entered into a series of commercial arrangements in which Foundation’s tumor analysis and cancer genetics capabilities will be incorporated into Roche’s clinical development platform.  The companies will also collaborate to co-develop novel cancer diagnostics as well as to educate physicians about genetic informatics-based cancer care. 
Continue Reading JP Morgan Conference Highlights eHealth Technologies, Data-Driven Therapeutics

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 even our bodies” results in increased data sensitivity and heightened challenges for consumer protection.  Those challenges, according to Ramirez, stem from three overarching issues: (1) ubiquitous data collection; (2) using data in ways consumers don’t expect (and the adverse consequences of such use); and (3) heightened security risks.

While FTC has been focused on consumer issues raised by the “Internet of Things” (IoT) era for quite some time, the examples cited by Ramirez suggest that e-health products are among the IoT applications of greatest salience when it comes to consumer protection.  She specifically called out smart glucose meters, heart monitors and health monitoring wearables in the speech.
Continue Reading FTC Remarks Signal Heightened Focus on Mobile Health 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