Bill of Health

JANUARY 19, 2022

Factors Associated with Compliance to the Hospital Price Transparency Final Rule: a National Landscape Study. Anticancer Drugs Approved by the US Food and Drug Administration From 2009 to 2020 According to Their Mechanism of Action. A full posting of abstracts/summaries of these articles may be found on our? JAMA Intern Med.

COVID-19 176

COVID-19 Medicaid Medicaid FDA 176

Health Law Advisor

MAY 3, 2022

We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. Just a short while ago FDA recommenced inspections.

FDA 52

FDA Compliance 52

HIT Consultant

MAY 9, 2022

The transition toward more digital recordkeeping in healthcare began in earnest in 2009 with the passage of the American Recovery and Reinvestment Act. With mountains of paperwork generated every year, achieving complete patient privacy and 100 percent compliance can be difficult.

FDA 98

FDA COVID-19 Public Health Compliance 98

HIPAA Journal

NOVEMBER 4, 2022

The Department of Health and Human Services (HHS) is the Sector Risk Management Agency (SRMA) for the healthcare industry, but within the HHS agencies such as the Office for Civil Rights (OCR), Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA) have their own jurisdictions and cybersecurity policies.

HIPAA 116

HIPAA Governance FDA Medicaid 116

HIT Consultant

JANUARY 28, 2022

Big Health , a digital therapeutics company dedicated to helping millions back to good mental health, today announced that it has added former Food and Drug Administration (FDA) Deputy Commissioner for Medical and Scientific Affairs Dr. Anand Shah to its Board of Directors.

Electronic Medical Records 98

Electronic Medical Records FDA Compliance Hospitals 98

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance 52

Compliance FDA Governance State Policy 52

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. 2009) (citations omitted).

FDA 52

FDA Compliance Fraud Hospitals 52