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Keeping you afloat admidst the rising sea of regulations

FDA Announces Innovation Plan to Reboot Digital Health Device Regulation

What’s New?Regulators are taking strides to focus their attentions on the digital health landscape, as we’ve recently seen from the FCC,

Congress on Notice: Health Care Cybersecurity is in Critical Condition

Earlier this month, the Health Care Industry Cybersecurity Task Force sent to Congress the Report On Improving Cybersecurity in the Health Care Industry.

Not Just for Health Care Providers Anymore: Health IT Vendor Pays $155 Million to Settle False Claims Act Case

Last week, eClinicalWorks (ECW)—an electronic health records (EHR) vendor—settled an intervened False Claims Act case with the Department of Justice for $155 million.

Tally-ho! Flurry of Legislative Activity Signals Ease on Federal Barriers to Telehealth

What’s New?In recent months, a number of bills have been introduced or passed in Congress that would ease federal health care programs’ restrictions on telehealth. Currently, Medicare has strict limitations on telehealth. But bipartisan groups of Senators have introduced two bills seeking to expand telehealth services covered by Medicare.

Approval of Privacy Shield Provides Framework for Transfer Personal Data between the US and EU

What’s New?After months of negotiations, it’s official: the EU-US Privacy Shield has been formally approved on both sides of the Atlantic, by the EU Commission and the US Commerce Department, despite concerns surrounding the adequacy of its earlier version.

What Do Self-Driving Cars and Your Heart Monitor Have in Common? The Same Questions About Cybersecurity.

Arent Fox partner Sarah Bruno recently published a very interesting alert on new privacy and cybersecurity challenges facing the automotive industry in the age of autonomous vehicles, syncing software, and wearable devices that interact with your vehicle.

AMA Adopts Ethical Guidelines for Telemedicine, Finally

Telemedicine has been growing by leaps and bounds over the past decade, moving beyond teleradiology to include a broad range of specialties such as neurology, infectious diseases, and psychiatry. However, this expansion has not been without controversy, as highlighted by the American Medical Association’s (AMA) recent adoption of guidance for the ethical practice in telemedicine.

Joint Developments Raise Intellectual Property Concerns

*This article was originally published by For the Record.   In order to improve patient care and internal IT operations, medical centers often need to enter joint development agreements with software companies and other technology vendors. Developing wearable medical devices, mobile and cloud-based services, and even "software as a medical device" requires a combination of the skills used to construct each of them.   However, joint collaborations can lead to unexpected intellectual property (IP) results and business outcomes.