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HIPAA

BioSig-ID™ has application for use in multiple HIPAA applications.

"FLASH" IN SEPTEMBER 2008 - The first ever HIPAA enforcement fine and "Corrective Action Plan" has been levied against a non-profit hospital system with operations in multiple states. This enforcement action dramatically changes the environment of HIPAA enforcement.

The CAP lasts for three years and requires the hospital to perform audited remediation tasks and reviews including conducting a risk assessment and audited "monitor reviews" on a quarterly basis. Hospital agreed to pay a $100,000 fine and costs associated with the CAP will far exceed the monetary fine. The action resulted from a series of events involving lost data storage devices and laptops with multiple exposures of protected information over a period of several months.

"the agreement calls for the hospital's chief information security officer to personally validate that all required policies have been put in place and that all employees have been trained on adhering to them. The CISO also has to attest that all backup media and portable devices containing health information protected by HIPAA are properly secured."

Beginning in 2005, The Health Insurance Portability and Accountability Act (HIPAA) requires the healthcare industry to implement encryption, user authentication and other security measures to safeguard the integrity, confidentiality and availability of electronic data. For HMOs, PPOs, healthcare providers, lawyers and others in the chain of organizations that exchange electronic data, failing to meet these requirements can lead to civil and criminal penalties up to $250,000 and jail terms.

The sweep of the HIPAA security requirements is broad, covering any organization that generates or otherwise handles electronic patient records and other e-medical data. Those affected include virtually all government and private hospitals, outpatient centers, nursing centers, HMOs, PPOs, insurance companies, firms providing clinical information systems for medical labs, including school nurses, school athletic directors, providers of pathology, radiology, patient billing, pharmacy records, medical software application providers and even related web portal companies.

The pharmaceutical industry has similar requirements imposed by the Food and Drug Administration (FDA) as outlined in "21 CFR Part 11; Electronic Records; Electronic Signatures Validation." Under 21 CFR Part 11, pharmaceutical companies must ensure that electronic records and electronic signatures are trustworthy and reliable. Clinical trial records and all other records that must be created, maintained and transmitted per requirements set forth by FDA regulations will benefit from the straightforward, yet secure, services offered by BioSig-ID™.

BioSig-ID™ helps enable these healthcare organizations to be HIPAA and 21 CFR Part 11 compliant, using digital signatures that authenticate and vouch for the content of medical and associated records, providing audit trails, and can securely help transport such records to ensure privacy.

Create electronic originals of your medical, insurance and clinical trial documents and electronically sign them to create a permanent, reliable record.

Have patients sign in to verify services rendered, have patients sign in to authorize



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