All posts by Amy Palermo

HIPAA Breach

To Report Or Not To Report A HIPAA Breach

Use these evaluation and prevention strategies to minimize fines and breaches

As a HIPAA-covered entity, your medical establishment is required by the HIPAA Breach Notification Rule to provide notification following a breach of unsecured protected health information (PHI). Depending on the number of individuals your PHI breach affects, you may need to notify each affected individual, More..

FDA Food Facility Inspection

Prepare For 3 Phases Of An FDA Food Facility Inspection

The secret to a passing grade depends as much on what you don’t say as what you do

Every year, millions of Americans get sick—and some even die—because of foodborne diseases, according to the Centers for Disease Control and Prevention. With the passage of the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) is on a mission to prevent foodborne More..

Hospital Contracted Services

Prepare Your Hospital For Contracted Services Scrutiny

Ensure You And Your Vendors Know Your CMS & Joint Commission Obligations

Both the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission have ramped up their scrutiny of contract management at hospitals—and with good reason. Data breach and communication breakdown are very real risks given that multiple hospitals departments are regularly accessing the contracts More..

FDA Regulatory Compliance

Avoid Failed Regulatory Efforts And FDA Form 483

Find Out Why an Organization-Specific Compliance Program Is So Important

If your life science organization fails to meet regulatory requirements during a Food and Drug Administration (FDA) audit, you can expect to receive a Form 483. While some 483 observations are resolved amicably, other cases have serious consequences for the concerned organization— ranging from warning More..

DME Documentation Guidelines

Put Your Best Foot Forward To Avoid DME Denials

Sidestep Revenue Loss: Follow Proper CMS Documentation Guidelines

Durable medical equipment (DME) billing continues to be scrutinized by Medicare and other commercial carriers. The Centers for Medicare and Medicaid Services (CMS) offers extensive and detailed documentation guidelines for DME in general, as well as other guidelines for documentation that can be found in More..