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Freedom of Information Act Healthcare

The Freedom of Information Act is a United States federal statute enacted in 1966 to promote government transparency and the free exchange of public information. Under FOIA, any individual can request federal... more +
The Freedom of Information Act is a United States federal statute enacted in 1966 to promote government transparency and the free exchange of public information. Under FOIA, any individual can request federal agency records and enforce that right in a court of law. However, not all agency records can be requested; there are nine exempt categories of information. In addition to the federal law, many states have passed their own freedom of information acts. These acts are often similar but not always identical to the federal version.  less -
Epstein Becker & Green

Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not...

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that...more

Troutman Pepper

Accepting Anonymous Tips: FDA's Website for Reporting Medical Device Regulatory Misconduct

Troutman Pepper on

For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead. Unidentified tipsters — from disgruntled former employees to plaintiffs’ attorneys —...more

Davis Wright Tremaine LLP

Are Attorneys Entitled to “HIPAA Rate”?

Over the past year, numerous lawsuits and complaints to the HHS Office for Civil Rights (“OCR”) have been filed by plaintiffs’ attorneys over a seemingly obscure HIPAA issue – the rate that health care providers and their...more

King & Spalding

CMS Proposes Sweeping Changes to Medicare Reimbursement for Clinical Diagnostic Laboratory Tests

King & Spalding on

First Data Collection Period for Clinical Laboratories Is July 1, 2015 to December 31, 2015 - In the October 1, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule...more

Mintz - Health Care Viewpoints

Increased Availability of Health Care Data Means More Oversight and More Litigation

The increasing availability of health care claims and payment data may portend the future of government and private health care enforcement and litigation. ...more

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