NIH grants Eko $2.7M to develop pulmonary hypertension AI tech

[Image from Eko]Eko announced today that it received a $2.7 million Small Business Innovation Research (SBIR) Direct Phase II grant.

The National Institutes of Health’s (NIH) Department of Health and Human Services (HHS) awarded the grant. The grant will fund the development of a machine learning algorithm, according to a news release.

Eko said the algorithm detects and stratifies pulmonary hypertension (PH). It uses phonocardiogram (PCG) and electrocardiogram (ECG) data from Eko’s smart stethoscopes. To address challenges of ECG-based AI models for detecting PH, Eko partnered with Lifespan Health System’s Cardiovascular Institute.

The partnership collects real-world PCG and ECG data using the Eko Duo ECG + digital stethoscope. Eko plans to use the data to develop an algorithm that can detect PH and stratify its severity. Early identification can diagnose PH earlier and more accurately, leading to potentially life-saving interventions.

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How safe is health information after the overturning of Roe?

[Image from Unsplash]The U.S. Department of Health and Human Services today issued guidance meant to better protect women’s health information as state abortion bans kick in after the U.S. Supreme Court’s overturning of Roe v. Wade.

Despite the HHS actions, women may still wonder whether their health information is entirely safe going forward — a potential challenge for the creators of digital health software.

The new HHS Office for Civil Rights (OCR) guidance addresses when the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule permits disclosure of PHI without an individual’s authorization. Its release comes amid calls on social media for women to delete period tracking apps. (The New York Times, however, reports that the opposite is happening, with a Berlin-based period-tracking app company called Clue saying it would not comply with U.S. law enforcement seeking information.)

Get the full story on our sister site Medical Design &…

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HHS offers guidance for HIPAA-compliant audio telehealth

The HIPAA Security Rule does not apply to audio-only telehealth services provided via landline, but does apply to calls over cellular and internet connections. (Imagy by Frederik Lipfert on Unsplash)

The Office for Civil Rights at the U.S. Department of Health and Human Services today issued guidance on providing audio-only telehealth services in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

“Audio telehealth is an important tool to reach patients in rural communities, individuals with disabilities, and others seeking the convenience of remote options,” Office for Civil Rights Director Lisa Pino said in a news release. “This guidance explains how the HIPAA rules permit health care providers and plans to offer audio telehealth while protecting the privacy and security of individuals’ health information.”

HHS said the guidance is meant to ens…

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U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health

U.S. Department of Health and Human Services (HHS)

U.S. Dept. of Health and Human Services (HHS) announced that it formed a new research project agency for health.

HHS Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health (NIH). Adam H. Russell was appointed as acting deputy director, effective next month.

Get the full story at our sister site, Drug Discovery & Development.

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HHS to support more healthcare products manufacturing

HHS will fully establish a program to provide loans, grants and other types of funding to expand the U.S. health resources industrial base, the White House announced today.

The news was part of a package of actions the Biden administration is taking to support American manufacturing and boost supply chains.

During the COVID-19 pandemic, HHS created a Defense Production Act office to use the Korean War–era law to break through bottlenecks in the supply chain and spend funds to combat shortages of needed medical supplies. Now, HHS will fully establish a DPA Title III Program.

Today’s announcement out of the White House also included news that the Treasury Department will deploy $10 billion of American Rescue Act funds under a new and improved State Small Business Credit Initiative (SSBCI). The move will leverage the funds into more than $70 billion in additional lending and investment for small businesses, including small manufacturers.

Get th…

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Senate confirms new CMS leader

The U.S. Senate today confirmed President Joe Biden’s selection to lead CMS, Chiquita Brooks-Lasure, with a 55-44 vote in favor.

Brooks-Lasure will be the first Black woman to hold the position, according to Senate Majority Leader Chuck Schumer (D-N.Y.) on Twitter. She previously served in the U.S. Dept. of Health and Human Services during the Obama administration, during which time she helped to implement the Affordable Care Act, which she will now oversee as the Biden administration seeks to expand it.

Get the full story at our sister site, MassDevice.

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Xavier Becerra confirmed as HHS secretary

Image from Gage Skidmore on Flickr

The U.S. Senate narrowly voted to confirm Xavier Becerra as the secretary of the U.S. Dept. of Health & Human Services (HHS) today.

Becerra received the nomination for the position from President Joe Biden in December 2020. Today, the Senate voted 50-49 in favor of Becerra, who will have to resign his seat as the attorney general of California. He will succeed Alex Azar, who held the position during the Trump administration until his resignation just days before Biden’s inauguration.

Democrats unanimously backed his nomination in the Senate, while Republican senators were nearly united in opposing his confirmation, claiming Becerra’s past, which included Democratic legal challenges to policies from the Donald Trump administration, made him unfit for the position.

Becerra, a 12-term veteran of U.S. Congress, had previously advocated for healthc…

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HHS pulls FDA back from regulating some COVID-19 tests

[Photo by Fusion Medical Animation on Unsplash]

FDA will no longer require a premarket review of laboratory-developed tests during the COVID-19 pandemic, according to a decision announced on the U.S. Department of Health and Human Services website.

Such a requirement in the future will need notice-and-comment rulemaking versus guidance documents, compliance manuals, website statements or other informal issuances, HHS said in the decision posted Aug. 19.

The decision stated: “The Trump Administration is committed to combating COVID-19, to ensuring that the American people are protected against future pandemics, and to keeping duplicative regulations and unnecessary policies from interfering with those efforts.”

The move appears to have surprised FDA insiders and comes after disagreements between HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn, according to The Washington Post,…

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