Food and Drug Administration

Protected in Name Only: HIPAA’s Health Data Gap Is Becoming a National Security Risk

Protected health data is only as secure as the system designed to protect it.

HHS Proposes Clinical Trial Reform To Catch Chinese Biotech Sector

The United States is looking to catch up with China’s expanding biotechnology sector. On June 23, the Department of Health and Human Services (HHS) issued a new proposal to accelerate clinical trials...

China’s State Support and Pricing Practices in the Biotechnology Sector

Impact on U.S. Industry

New Standards Aim to Protect Medical Patients from the ‘Internet of Things’

Cybersecurity in healthcare may finally be getting its overdue visit to the doctor’s office. The National Institute of Standards and Technology (NIST) is developing new cybersecurity guidance for...

NIH Controlled-Access Data Policy and Proposed Revisions to NIH Genomic Data Sharing Policy

Reimagining and Improving Student Education

Section 232 National Security Investigation of Imports of Personal Protective Equipment, Medical Consumables, and Medical Equipment, Including Devices

The U.S. Will Rely on China To Defend Against the Next Pandemic

Despite the lessons of the pandemic, America’s biodefense system increasingly relies on Chinese components. On October 14, the U.S. Pharmacopeia (USP), a body that sets domestic quality standards for...

Medical Devices Still Vulnerable to Hacking Despite New FDA Guidance

Machines such as pacemakers, insulin pumps, and vital signs monitors are the difference between life and death for millions of people, and they are all vulnerable to cyberattack. In its effort to protect...

Swift U.S. Response Needed to Contain Mpox Outbreak in Africa

The director general of the World Health Organization (WHO) declared a public health emergency of international concern (PHEIC) on August 14 due to a surge in cases of mpox, formerly known as monkeypox,...

Charting FDA’s Course: SBOM as the North Star in Cybersecurity

Supply chain security has undergone a profound transformation after pivotal events such as the SolarWinds compromise in 2020 and the subsequent Log4j incident.  Central to this evolution is the emergence...

How the US monkeypox response failed to learn COVID’s lessons

Excerpt The Biden administration’s failed response to the spread of monkeypox has highlighted America’s inability to respond to large-scale disease outbreaks. These problems are bipartisan and were...

Cyber Vulnerabilities in Medical Devices Put Patients at Risk

The Food and Drug Administration (FDA) closed the public comment period earlier this month on draft cybersecurity guidance for new medical devices after receiving more than a thousand comments from patients,...

The WHO’s Fraudulent Procurement of Chinese PPE Holds Important Lessons for U.S.

The World Health Organization (WHO) violated its own procurement guidelines by improperly awarding contracts worth hundreds of millions of dollars to a Chinese state holding company, according to an external...

Is Covid-19 China’s attempt to wage a silent war?

‘In a world following silent biological warfare, the instigating nations will be the quickest to recover, and ultimately lead the new world order. If this is indeed a sci-fi scenario, caused by Chinese...

FDA Takes Important Step to Securing Medical Devices

The Food and Drug Administration (FDA) earlier this month named its first-ever acting director of medical device cybersecurity, Kevin Fu. This is an encouraging, if belated, step towards strengthening the...

How to Decouple Key Supply Chains from China

The great power competition between Washington and Beijing is heating up. The U.S. effort to contain China’s rise is now on full display, as the Trump administration (rightly) blames China for failing...