Posts Tagged ‘HIPAA’

$210 per compromised medical record

October 20th, 2009

 I was surprised to see the average cost of a data breach exceeded $210 per compromised record, creating an opportunity for computer crime rings to traffic in stolen medical records, according to a study sponsored by LogLogic.

The study shows patients may be surrendering their privacy as the $2.5 trillion medical industry pushes to accelerate the pace of digitizing health information records, prompted by federal stimulus funding.
According to the report the new HIPAA rules will help improving 
the protection of medial records. (see my post on new HIPAA rules)


General, Market ,

HIPAA and 21CFR11 overlaps

October 12th, 2009

Both HIPAA and 21 CFR Part 11 are concern with safeguarding Data. While 21CFR11 applies to Life Sciences Organizations (LSO), HIPAA applies to Healthcare Providers (HCP) and other "covered entities", such as insurance companies.

21 CFR Part 11 sets out the procedural and system requirements for controlling and auditing electronic records and signatures. It requires employing procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records.
Similarly HIPAA security rules are described as followed:
Physical Safeguards
Facility access controls
Work station use
Work station security
Device & Media controls
Technical Safeguards
Access control
Audit control
Integrity controls
Person or entity authentication
Transmission security
Administrative Safeguards
Security and access management
Secure incident handling
and implement policies and procedures to prevent, detect, contain and
correct security violations.
There are obvious requirement overlaps around
- Operational policies and SOPs 
- System and Record Access Control
- Audit trail
- Record keeping and retention
It just makes sense to start consolidating these requirements into one set. 
This has to happen sooner or later as we start sharing standardized medical records between healthcare providers and Pharmaceutical companies for Clinical Trials or Adverse Events reporting.

General, Technology , ,

Stimulus Package Includes Changes to HIPAA Rules

March 24th, 2009

 According to new legislation, physicians now will be required to track any disclosure of a patient’s medical information. Previous regulations allowed physicians to disclose patient information for the purpose of treatment, payment or health care operations, but they were not required to track when that information was disclosed. 

However, this should be easy to manage for physicians who use an electronic health record as hopefully EHR vendors will provide such a functionality out-of-the-box to track every time patient information is disclosed.
In addition, the legislation requires practices to post information about security breaches if a breach affects 10 or more patients and must notify all of their patients, a local media outlet, and the HHS secretary if the breach affects 500 or more patients.

General, Technology ,