Articles and Blogs

Health Information Technology

Final FDA Guidance on Interoperable Medical Devices

[09/20/17]

Posted on September 20, 2017 in Health Information Technology

Published by: Hall Render

On September 6, 2017, the U.S. Food and Drug Administration (“FDA”) published final guidance (“Guidance”) summarizing its recommendations for medical devices that are connected to each other and to other technology (“interoperable medical devices”). The Guidance finalizes preliminary guidance from January 2016 and is intended to encourage rapid innovation in the marketplace by allowing... READ MORE

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Meaningful Use Hardship Exception Deadline Approaching

[09/14/17]

Posted on September 14, 2017 in Health Information Technology

Published by: Hall Render

Eligible Professionals participating in the Medicare Meaningful Use Electronic Health Record Incentive Program have until October 1, 2017 to submit a hardship application to avoid a downward payment adjustment in 2018. A participant may submit a hardship application if the Eligible Professional: Is a first-time Eligible Professional who intends to participate in the advancing care information performance... READ MORE

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eClinicalWorks Settlement – Impact on Providers

[06/08/17]

Posted on June 8, 2017 in Health Information Technology

Published by: Hall Render

The news of the $155 million settlement between eClinicalWorks (“eCW”), several eCW employees and the U.S. Department of Justice has left many current users of the eClinicalWorks EHR (“eCW EHR”) wondering what impact it will have upon them. First, the terms of the settlement provide several rights to current users. Second, actions taken to... READ MORE

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The MDLive Class Action: Understanding the Complex Relationship of Consumer Telehealth Platforms

[06/02/17]

Posted on June 2, 2017 in Health Information Technology

Published by: Hall Render

On April 18, 2017, a class action was initiated against MDLive, Inc. asserting that MDLive inappropriately collected and disclosed patient medical information. MDLive is a low acuity telehealth platform that enables patients to communicate with physicians via their smart phones, computers or other mobile devices. Without commenting on the merits of the specific claims... READ MORE

HHS Announces International Cyber Threat to Health Care Organizations

[05/12/17]

Posted on May 12, 2017 in Health Information Technology, Health Law News

Published by: Hall Render

On May 12, 2017, a massive cyber attack affecting health care organizations across the world prompted the United States Department of Health and Human Services (“HHS”) to issue a warning to U.S. health care organizations. The attack apparently first began in England, causing information systems at health care organizations throughout the country to become infected... READ MORE

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Attest to 2016 Medicare Meaningful Use Program Requirements by February 28

[01/17/17]

Posted on January 17, 2017 in Health Information Technology

Published by: Hall Render

This month, the Centers for Medicare & Medicaid Services opened the registration and attestation system for the Medicare Meaningful Use Incentive Payment Program for 2016.  Eligible providers participating in the Medicare Meaningful Use Incentive Payment Program must attest to the 2016 Medicare Meaningful Use Program requirements by February 28, 2017 at 11:59 PM EST in order... READ MORE

Defend Trade Secrets Act of 2016: Promoting Uniformity and How an Employer Can Obtain Heightened Damages for Unlawful Trade Secret Disclosures

[07/05/16]

Posted on July 5, 2016 in Health Information Technology

Published by: Hall Render

On May 11, 2016, President Barack Obama signed the Defend Trade Secrets Act of 2016 (“DTSA”)1 into law. The DTSA’s stated purpose is to bring trade secrets disputes into the federal courts, changing the system under which trade secret law was governed mostly by state law. As part of the DTSA, employers who wish... READ MORE

New FTC Guidance and Tools for Mobile Medical Apps

[05/04/16]

Posted on May 4, 2016 in Health Information Technology

Published by: Hall Render

On Tuesday, April 5, the Federal Trade Commission (“FTC”) released a new web-based tool for developers of health-related mobile apps. The tool asks mobile application developers questions about the mobile app’s function, the type(s) of data that the app collects and the service(s) that the app offers to end-users. The new tool then guides... READ MORE

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2015 Meaningful Use Attestation Deadline Extended

[02/11/16]

Posted on February 11, 2016 in Health Information Technology

Written by: Jeffrey W. Short

This week, the Centers for Medicare & Medicaid Services (“CMS”) announced that the attestation deadline for the Medicare Electronic Health Record Incentive Program (“Meaningful Use Program”) is changed from February 29, 2016 to March 11, 2016. The new deadline applies to all eligible professionals, eligible hospitals and critical access hospitals participating in the Meaningful... READ MORE

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Safe Harbor Agreement Between United States and EU Ruled Invalid

[10/06/15]

Posted on October 6, 2015 in Health Information Technology

Written by: Alisa C. Kuehn

For years, companies in the United States have relied on a Safe Harbor to the EU Directives (the stringent privacy requirements imposed by the European Union) to qualify for the ability to transfer protected data between EU countries and the United States. Today, however, the European Court of Justice ruled that the agreement between... READ MORE

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