CMS offers $1.65 million in AI Health Outcomes Challenge

By Jodi G. Daniel & Amber Mulcare

April 23, 2019

On March 27, 2019, the Centers for Medicare & Medicaid Services (CMS) announced a $1.65 million competition to accelerate development of AI solutions in health care. The Artificial Intelligence (AI) Health Outcomes challenge seeks innovative, AI-driven solutions that can predict unplanned hospital and skilled nursing facility (SNF) admissions and adverse events. The challenge is a 1-year, three stage competition; the Launch State is open to the public and seeks to attract a wide range of…

C&M Health Law

HHS Releases Voluntary Cybersecurity Practices Guidance

By Jodi G. Daniel & Amber Mulcare

January 14, 2019

In order to move health care organizations towards consistency in mitigating important cybersecurity threats to the health care sector, the Department of Health & Human Services (HHS) published multiple guidance documents on best practices for health care organizations to reduce cybersecurity risks (“HHS Cyber Guidance”). The HHS Cyber Guidance is the result of HHS’ public-private partnership with more than 150 cybersecurity and health care experts. While compliance is voluntary, this guidance serves as direction to…

C&M Health Law

FDA Issues New Guidance for the Management of Cybersecurity in Medical Devices

By John Fuson, Jodi G. Daniel, Amber Mulcare & Brandon C. Ge

October 19, 2018

Yesterday, the FDA released draft guidance on the management of cybersecurity in medical devices submitted to the agency for premarket review. Noting that cybersecurity threats to the healthcare sector have increased in number and severity, the FDA offered new recommendations for device design, labeling, and documentation that medical device manufacturers will need to consider during premarket submission processes. The guidance comes shortly after the FDA’s launch of its Medical Device Cybersecurity Playbook, which provides…

C&M Health Law

Congress Remains Focused on Electronic Health Records

By Jodi G. Daniel & Amber Mulcare

July 28, 2017

Congress is considering several adjustments to health IT policy which may have significant impact on the Centers for Medicare and Medicaid Services’ (“CMS”) electronic health records (“EHR”) incentives. On July 20th and 21st, Representatives met to discuss bipartisan legislation to improve the Meaningful Use program and introduced legislation that would authorize a CMS Innovation Center (“CMMI”) project to incentivize EHR adoption by behavioral health providers. The bills may be indicative of Congress’ attitude towards the…

Amber Mulcare

CMS offers $1.65 million in AI Health Outcomes Challenge

HHS Releases Voluntary Cybersecurity Practices Guidance

FDA Issues New Guidance for the Management of Cybersecurity in Medical Devices

Congress Remains Focused on Electronic Health Records

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