AI & Machine Learning in Biotechnology
STAT+: Epic says it has uncovered rot in patient record sharing. Will HHS act?
In a recent court filing, electronic health records giant Epic Systems proved one of health care providers’ worst fears: Companies are posing as providers to gain access to patient records.
Health care providers holding those records can’t legally refuse the request. But if they share the records with someone who doesn’t have rights to them, they violate HIPAA, the federal law that protects patients’ health information.
Regardless of the outcome of the lawsuit itself, Epic has opened up a Pandora’s box, forcing the federal health department to consider policy changes to assuage providers’ fears. Even as experts agree on the need for more regulatory clarity, they worry about any changes, whether directly or indirectly, being dictated by the industry’s biggest player.
In a recent court filing, electronic health records giant Epic Systems proved one of health care providers’ worst fears: Companies are posing as providers to gain access to patient records.
Health care providers holding those records can’t legally refuse the request. But if they share the records with someone who doesn’t have rights to them, they violate HIPAA, the federal law that protects patients’ health information.
Regardless of the outcome of the lawsuit itself, Epic has opened up a Pandora’s box, forcing the federal health department to consider policy changes to assuage providers’ fears. Even as experts agree on the need for more regulatory clarity, they worry about any changes, whether directly or indirectly, being dictated by the industry’s biggest player.
AI & Machine Learning in Biotechnology
STAT+: ‘We’re on the inside now’: Meet the man building a political empire behind RFK Jr.
WASHINGTON — In the past three years, Robert F. Kennedy Jr. has had a dramatic ascent, rocketing from the contrarian fringe to the center of the American health system and leader of a burgeoning political movement. At every step, he’s been bolstered behind the scenes by a lesser-known name: Tony Lyons.
A longtime publisher and ally of Kennedy’s, Lyons has built a sprawling political operation to promote Kennedy and his “Make America Healthy Again” brand, a multimillion-dollar endeavor that spans multiple nonprofits, businesses, and a political action committee — one could call it “MAHA Inc.” Under the MAHA banner, Lyons hosts administration officials as he plays emcee on weekly activist organizing calls, holds glitzy cocktail parties at an exclusive D.C. club, and convenes events around the country.
Since his campaign, the MAHA Inc. network has amplified Kennedy’s message and ideas, celebrating Kennedy’s overhaul of the nation’s vaccine system and efforts to revamp its food supply. Increasingly, the network is also cheerleading for President Trump, even as other prominent MAHA activists are critical of some of his administration’s recent moves.
WASHINGTON — In the past three years, Robert F. Kennedy Jr. has had a dramatic ascent, rocketing from the contrarian fringe to the center of the American health system and leader of a burgeoning political movement. At every step, he’s been bolstered behind the scenes by a lesser-known name: Tony Lyons.
A longtime publisher and ally of Kennedy’s, Lyons has built a sprawling political operation to promote Kennedy and his “Make America Healthy Again” brand, a multimillion-dollar endeavor that spans multiple nonprofits, businesses, and a political action committee — one could call it “MAHA Inc.” Under the MAHA banner, Lyons hosts administration officials as he plays emcee on weekly activist organizing calls, holds glitzy cocktail parties at an exclusive D.C. club, and convenes events around the country.
Since his campaign, the MAHA Inc. network has amplified Kennedy’s message and ideas, celebrating Kennedy’s overhaul of the nation’s vaccine system and efforts to revamp its food supply. Increasingly, the network is also cheerleading for President Trump, even as other prominent MAHA activists are critical of some of his administration’s recent moves.
AI & Machine Learning in Biotechnology
STAT+: FDA approves Rocket gene therapy for rare immune disorder
The Food and Drug Administration approved on Thursday a gene therapy for severe leukocyte adhesion deficiency type 1 (LAD-1), an ultra-rare disease that leaves children vulnerable to life-threatening infections.
The therapy, marketed as Kresladi, was developed by Rocket Pharma. It was initially rejected by the FDA in 2024 over manufacturing concerns.
Though Rocket is likely to charge millions of dollars for the one-time treatment, Kresladi is not expected to be a major money maker. LAD-1 is thought to affect only around 1 in a million people, with Rocket estimating around 25 new cases per year. The treatment is approved only for children who don’t have a matched sibling who can give a stem cell transplant, the standard of care in the disease.
The Food and Drug Administration approved on Thursday a gene therapy for severe leukocyte adhesion deficiency type 1 (LAD-1), an ultra-rare disease that leaves children vulnerable to life-threatening infections.
The therapy, marketed as Kresladi, was developed by Rocket Pharma. It was initially rejected by the FDA in 2024 over manufacturing concerns.
Though Rocket is likely to charge millions of dollars for the one-time treatment, Kresladi is not expected to be a major money maker. LAD-1 is thought to affect only around 1 in a million people, with Rocket estimating around 25 new cases per year. The treatment is approved only for children who don’t have a matched sibling who can give a stem cell transplant, the standard of care in the disease.
AI & Machine Learning in Biotechnology
STAT+: HHS convenes health care execs, motivational speaker on panel to modernize health care
WASHINGTON — A motivational coach, a venture capitalist who worked with health secretary Robert F. Kennedy Jr.’s son, and a number of health care executives whose firms span value-based care, mental health, and primary care have been tapped to advise federal officials on how to improve and modernize the health care system.
The members of the new advisory group, called the Healthcare Advisory Committee, were named Thursday by Kennedy and Centers for Medicare and Medicaid Services Administrator Mehmet Oz. In a video announcement, Kennedy said officials reviewed more than 400 candidates before settling on 18 who will drive Kennedy’s Make America Healthy Agenda by developing policy on tackling chronic diseases, reducing administrative burden, and enhancing care for vulnerable populations.
“Their insights will help us cut costs, slash red tape, improve quality of care, keep programs solvent, and refocus health care on the people it is meant to serve: the patients,” Oz said.
WASHINGTON — A motivational coach, a venture capitalist who worked with health secretary Robert F. Kennedy Jr.’s son, and a number of health care executives whose firms span value-based care, mental health, and primary care have been tapped to advise federal officials on how to improve and modernize the health care system.
The members of the new advisory group, called the Healthcare Advisory Committee, were named Thursday by Kennedy and Centers for Medicare and Medicaid Services Administrator Mehmet Oz. In a video announcement, Kennedy said officials reviewed more than 400 candidates before settling on 18 who will drive Kennedy’s Make America Healthy Agenda by developing policy on tackling chronic diseases, reducing administrative burden, and enhancing care for vulnerable populations.
“Their insights will help us cut costs, slash red tape, improve quality of care, keep programs solvent, and refocus health care on the people it is meant to serve: the patients,” Oz said.
Illinois’ financial crisis could bring the state to a halt
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New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
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STAT+: Pharmalittle: We’re reading about FDA backing domestic production, another Gilead deal, and more
FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
Sanofi Bispecific Scores in Asthma, Rhinosinusitis, but Eczema Bet Doesn’t Pay Off
STAT+: Gilead to buy cancer biotech Tubulis for more than $3 billion
Gilead continues dealmaking streak with $3.15B Tubulis buy for ADCs
BioNTech to shutter Singapore HQ after ‘comprehensive review’
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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