Compliance Regulations and Guidance Affecting your Industry

The Federal Deposit Insurance Corporation has issued guidance on safeguarding customers against E-mail and Internet-Related Fraudulent Schemes.

The California Online Privacy Protection Act of 2003 or OPPA, which became effective on July 1, 2004, was the first state law that required owners of commercial websites or online services to post a privacy policy.

The Payment Card Industry (PCI) Data Security Standard (DSS) was developed to encourage and enhance cardholder security and facilitate broad adoption of consistent data security measures globally.

The PCI DSS provides a baseline of technical and operational requirements designed to protect cardholder data.
 

This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0, supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June 9, 1997.

This guidance applies to:

• Software used as a component, part, or accessory of a medical device;
• Software that is itself a medical device (e.g., blood establishment software);
• Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
• Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

This standard establishes requirements for Balancing Authority Automatic Generation Control (AGC) necessary to calculate Area Control Error (ACE) and to routinely deploy the Regulating Reserve. The standard also ensures that all facilities and load electrically synchronized to the Interconnection are included within the metered boundary of a Balancing Area so that balancing of resources and demand can be achieved

The Payment Card Industry (PCI) Data Security Standard (DSS) was developed to encourage and enhance cardholder data security and facilitate the broad adoption of consistent data security measures globally. This document, PCI Data Security Standard Requirements and Security Assessment Procedures, uses as its foundation the 12 PCI DSS requirements, and combines them with corresponding testing procedures into a security assessment tool. It is designed for use by assessors conducting onsite reviews for merchants and service providers who must validate compliance with the PCI DSS. Below is a high-level overview of the 12 PCI DSS requirements. The next several pages provide background about preparing for, conducting, and reporting a PCI DSS assessment, whereas the Detailed PCI DSS Requirements begin on page 13.