Health Populi

FEBRUARY 27, 2020

23% of households had zero or negative net worth in 2017, up from 16% in 2001. The research calls out that consumers’ retirement concerns are declining physical health and running out of money. A further datapoint in the McKinsey social contract report is that over half of individuals in wealthy countries, including the U.S.,

Health Insurance 93

Health Insurance Public Health Governance 93

Bill of Health

AUGUST 16, 2022

In 2001, prosecutors charged McKnight with homicide allegedly caused by her use of cocaine while pregnant. At the young age of 21, Regina McKnight unexpectedly suffered a stillbirth due to umbilical inflammation. She was a grieving mother, but to the state of South Carolina, she was a killer.

Bioethics 130

Bioethics Hospitals Public Health 130

The Digital Health Corner

JANUARY 19, 2017

In a previous post I discussed important public health issues that digital technology can address. According to the National Institute on Drug Abuse (NIDA) from 2001 to 2014, deaths due to overdoses in the USA were noted as: 8 fold increase due to prescription drugs. Among them is drug addiction. 6 fold increase due to heroin.

ACA 60

ACA Public Health Governance 60

Bill of Health

APRIL 7, 2022

Article 6 of the TRIPS states that “the exhaustion of intellectual property rights” is left to “each Member free to establish its own regime for such exhaustion without challenge,” a topic that was front and center of the 1998 to 2001 litigation between drug companies and South Africa.

COVID-19 363

COVID-19 COVID-19 Vaccine Licensing Public Health 363

HIT Consultant

JULY 25, 2023

Josh Rubel, CCO, MDClone Suicide is a major public health crisis in America, resulting in one death every 11 minutes, on average. For example, in each year from 2001 through 2020, age- and sex-adjusted suicide rates of veterans exceeded those of non-veteran U.S. Centers for Disease Control and Prevention.

Department of Veterans Affairs 52

Department of Veterans Affairs Public Health 52

SQA

SEPTEMBER 2, 2022

The new guidance from the European Medical Device Coordination Group (MDCG) covers “borderline products” not easily categorized either as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

APRIL 30, 2021

In addition, considering the fact that one marketing authorization application is submitted in accordance with Article 8(3) of Directive 2001/83/EC and the other marketing authorization application is submitted under an abridged procedure (e.g., Under Article 82(1) of Regulation (EC) No.

COVID-19 Vaccine 52

COVID-19 Vaccine COVID-19 Compliance Governance 52

SQA

DECEMBER 16, 2022

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities.

FDA 40

FDA Compliance COVID-19 Licensing 40

Bill of Health

SEPTEMBER 1, 2023

Treatments are available almost exclusively in the private health care sector only, with only certain health insurance providers funding treatment. This leaves individuals who are out of pocket, or who have access to only public health care facilities without access to treatment.

Health Insurance 157

Health Insurance Public Health Doctors 157

Hall Render

JULY 14, 2023

billion behavioral health contract to Centene Idaho Drops Panel Investigating Pregnancy-Related Deaths as US Maternal Mortality Surges Kootenai Health CEO to retire after nonprofit conversion Kootenai Health on track for nonprofit conversion Ammon Bundy a no-show for beginning of St. How did we get here?

US Department of Health and Human Services 40

US Department of Health and Human Services Nursing Homes Nurses Hospitals 40

Drug & Device Law

OCTOBER 20, 2023

341 (2001), is so important. Indeed, “courts owe significant deference to the politically accountable entities with the ‘background, competence, and expertise to assess public health.’” That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S. FDA , 715 F.3d 3d 922, 927 (D.C. 2013) (Kavanaugh, J.).

FDA 59

FDA Pharmaceutical Industry Public Health 59

Drug & Device Law

JANUARY 4, 2024

The PREP Act goes into effect upon a federal declaration of public health emergency. The relevant legislative history demonstrates that Congress enacted the PREP Act in 2005: To encourage the expeditious development and deployment of medical countermeasures during a public health emergency. . . [by]

COVID-19 Vaccine 59

COVID-19 Vaccine COVID-19 FDA Public Health 59

Drug & Device Law

SEPTEMBER 22, 2023

Constitution’s Supremacy Clause, it strikes a balance between state and federal power on issues of public health and safety, and raises questions about whether our country’s approach to regulation and litigation makes sense for pharmaceuticals and medical devices (spoiler alert: it doesn’t). Can you blame us? This is good stuff!

FDA 105

FDA Public Health 105