Special Report: Solve Document Retention Dilemmas with Integrated Digital Archiving

Integrated Digital Archiving

If you were asked to list the key elements of a marketing campaign, your list would probably include: Products, pricing and distribution; Market segmentation and positioning; Budget; Marketing objectives and metrics; Media mix; Campaign themes, design elements, offers, key messages and calls to action ; Production and fulfillment; Analysis of results.

If you’re like most marketers, your list probably didn’t include “document retention.” But it should because, thanks to an increasingly complex regulatory and business environment, the need for document management, retention and archiving has never been greater.

The Document Deluge

Companies create, distribute and receive enormous volumes of paper and electronic documents in the course of developing and promoting their company’s products and services, as well as from other day-to-day business activities. Take the health insurance industry, for example.

A typical pre-enrollment kit may contain a cover letter, literature about the insurer, product and promotional collateral for one or more healthcare plans, technical information, legal disclosures, and application forms. In addition, insurers often must produce multiple versions of each document because provisions and benefits can vary by geography and market segment. The same is true for materials distributed post-enrollment.

Document Retention: Why it Matters

The Health Insurance Portability and Accountability Act (HIPAA) requires healthcare providers, as well as other covered entities – including any business that handles, maintains, stores, or exchanges a patient’s health records or other related medical and personal information – to retain copies of some documents for six years from date of creation or from the date they were last in effect, whichever is later.¹ Under the Health Information Technology for Economic and Clinical Health (HITECH) Act, which took effect in February 2010, the Office of Civil Rights is directed to conduct periodic audits of covered entities and business associates, to ensure compliance. Penalties for willful noncompliance have increased to as much as $50,000 per violation, up to $1.5 million per year.²

Other industries face similar document retention regulations. For example, the FDA’s Food, Drug, and Cosmetic Act and related statutes impose specific document control and retention requirements on manufacturers of human drugs and biological products, animal drugs, medical devices, and food additives. Title 21, Subchapter C, Part 203 requires that records be kept for at least three years and must be “resistant to tampering, revision, modification, fraud, unauthorized use, or alteration; preserved in accessible and retrievable fashion; and available to permit copying for purposes of review, analysis, verification, authentication, and reproduction by the person who executed the form or created the record, by the manufacturer or distributor, and by authorized personnel of FDA and other regulatory and law enforcement agencies.” Records must be made available within two business days if requested by the FDA or other federal, state or local regulatory official.³In another instance, the National Association of Securities Dealers’ Regulation 3010 requires securities firms, stock brokers, banks and any financial institutions that fall under SEC or NASD jurisdiction to retain customer records and transaction data in a reviewable format and easily accessible place. Regulation 3110 requires member firms to maintain a retention program for all correspondence involving registered representatives.⁴