ComplianceOnline articles

Abstract:

There`s a lot of buzz around HCCs in the healthcare. But not everyone understands why and how to use them. Coding and auditing errors can have a negative impact on the organization’s revenue cycle. Hospital and clinical staff, including Directors, Auditors, CDI staff, Managers, CDI Clinicians and coding compliance and privacy staff should understand the key components of the HCC coding and auditing.

Abstract:

No hospital wants to receive a statement of deficiencies and plan of correction from the regulatory bodies. Non-compliance with the grievance requirements is the third most problematic area that invites investigation. What if a CMS surveyor shows up at your hospital unannounced? Is your hospital compliant with the all the grievance requirements by CMS, OCR, and the complaint standards by the Joint Commission or your accreditation organization?

Effect

Abstract:

Receipt and Storage of cGMP Controlled Raw Materials Regulations and Best Practices

Manufactures of drugs who lack a defined raw material processing have received FDA 483s and lost several batches of products. Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of cGMP Controlled Raw Materials is critical to Life sciences personnel to gain drug approvals.

Abstract:

The US FDA recently amended its cGMP and labeling regulations for medical gases. The chief impetus for modifying the regulation was the number of injuries and deaths where medical gas containers carrying gases other than oxygen were falsely connected to a healthcare’s facility oxygen supply s

Abstract:

Credit risk, market risk, operational risk, counterparty credit risk, interest rate risk, and capital floors – a list of things on the itinerary for Basel IV. While yet adjusting to the requirements of Basel III, the newer legislation will hit the financial market soon enough, bringing with it a flurry of rules to mitigate any signs of a financial crisis akin to the 2007-2009 collapse.

Basel IV reaches up and sets the bar higher for capital ade

Abstract:

Elemental impurities have been topic of discussion since 2009 when the ICH commenced work to provide an international standard to limit the impurities in drug products and ingredients. FDA too has released its guidance on the control of elemental impurities in consistent with the implementation of ICH’s Q3D Elemental Impurities guideline. Th

Abstract:

DHS Issues Guidance on HIPAA and Cloud Computing

Cloud computing, an indelible part of healthcare systems and networks today, will now be regulated and brought under the HIPAA fold. DHS released the guidance that details the requirements for cloud computing service providers (CSP providers), clarifying that CSPs that create, receive, maintain, or transmit PHI (

Abstract:

What`s Safe in Your Medicine Cabinet: Dietary Supplements in the U.S.

From regulating hormone levels to supplementing nutritional deficiencies in children, dietary supplements have a broad spectrum of needs to cater to. Popping a vitamin pill or biting down on an energy bar is not as simple as it once was though. The plethora of products available to supplement your diet are so staggering that regulating what reaches the consumer has

Abstract:

An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the reference drug. This has led to an outcry from patients and drug manufacturers as generics makers cannot be held legally responsible for any product defects. Both groups are demanding a change in current generics warnin

Abstract:

The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.

This article gives an overview and summary of the recommendations included in the FDA guidance.