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HIPAA Enforcement . Office of Civil Rights (Privacy)CMS (Transactions, Code Sets, Identifiers, Security)Justice DepartmentFBIOIG (Re: lessons learned from fraud
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1. Securing the EHR SystemMontana EHR Collaborative Carolyn Hartley
Physicians EHR, LLC
3. Summary of HIPAA Privacy RuleCompliance Activities HHS Office of Civil Rights (OCR)
12,542 complaints received as of Apr. 30, 2005
Filed against:
Private Health Care Practices
General Hospitals
Pharmacies
Outpatient Facilities
Group Health Plans
4. Summary of HIPAA Privacy RuleCompliance Activities (cont.) Allegations raised most frequently in the complaints are:
The impermissible use or disclosure of an individual’s identifiable health information
The lack of adequate safeguards to protect identifiable health information
The refusal or failure to provide the individual with access to or a copy of his or her records
The disclosure of more information than is minimally necessary to satisfy a particular request for information
The failure to have the individual’s valid authorization for a disclosure that requires one
5. 65% have been closed, because either:
OCR lacks jurisdiction under HIPAA
The activity alleged does not violate the Rule
Matter satisfactorily resolved through voluntary compliance Summary of HIPAA Privacy RuleCompliance Activities (cont.)
6. Case closures include those: where OCR lacks jurisdiction under HIPAA
such as a complaint alleging a violation prior to the compliance date or alleging a violation by an entity not covered by the Privacy Rule
where the activity alleged does not violate the Rule
such as when the covered entity has declined to disclose protected health information in circumstances where the Rule would permit such a disclosure
where the matter has been satisfactorily resolved through voluntary compliance
for example, where an individual is provided access to their medical record based on a complaint that such access had been previously denied.
7. 200+ referrals to the Dept. of Justice (DOJ) Summary of HIPAA Privacy RuleCompliance Activities (cont.)
8. The Role of Security in HIT Adoption Security: required before moving into electronic exchanges of protected health information
Security is as much about protecting your business assets as it is about protecting your electronic assets
10. Threats and Vulnerabilities (2)
11. CIA of HIPAA Security
12. Safeguards ePHI refers to electronic protected health information. Protected health information refers to any oral, written or electronic information that can be used to individually identify a patient. The Privacy Rule safeguards PHI in oral, written or electronic form. The Security Rule safeguards just the electronic information. ePHI refers to electronic protected health information. Protected health information refers to any oral, written or electronic information that can be used to individually identify a patient. The Privacy Rule safeguards PHI in oral, written or electronic form. The Security Rule safeguards just the electronic information.
13. Required or Addressable Required
You must comply with the rule
Addressable
Do what the rule says
Don’t do what the rule says, but document reason
Develop solution and document why this approach Each of the safeguards are either required or addressable. If a safeguard is required, then you must comply with the rule. If it is addressable, you have one of three choices. An addressable can be much more difficult because the practice must now determine whether to meet the requirement or find a solution that better matches the practice. For example one addressable standard is to conduct a background search on new employees. That would not be practical if the physician is hiring a family member to be an office manager. Each of the safeguards are either required or addressable. If a safeguard is required, then you must comply with the rule. If it is addressable, you have one of three choices. An addressable can be much more difficult because the practice must now determine whether to meet the requirement or find a solution that better matches the practice. For example one addressable standard is to conduct a background search on new employees. That would not be practical if the physician is hiring a family member to be an office manager.
14. The Case For Security Business Imperatives
Protect your practice
Inventory your hardware and software
Know where the inventory is kept
Know the value of your hardware, software, equipment
Conduct a risk assessment and evaluate threats and vulnerabilities
Develop a contingency plan Much of the Security Rule is just good business sense. Practices who said they would not bother to comply with the Security Rule have rethought that decision and are using the Security Rule to find good business practices. If moving to an electronic health record environment after April 21, 2005, security rule requirements must be in place. Much of the Security Rule is just good business sense. Practices who said they would not bother to comply with the Security Rule have rethought that decision and are using the Security Rule to find good business practices. If moving to an electronic health record environment after April 21, 2005, security rule requirements must be in place.
15. Contingency Plan Critical data backed up and stored
Emergency call list
Plan to restore systems
Plan to move into temporary office
Secure offsite storage?
Identify situations that may activate contingency plan
16. The Case for Security Legislative Imperatives
Required by law to comply with Security Rule by April 21, 2005
Periodic security training:
Log-in monitoring
Password management
Protection from malicious software
Security reminders
17. Risk Analysis in a Clinical Setting The required standard (Review system audit logs) means you must conduct regular review of system audit logs, perhaps only to find out if someone has tried to hack into your system.
Assigned access is addressable because in a small office, the receptionist may also be the billing clerk and the system administrator.
The point in each case is that the practice needs to document how they plan to comply with the standard.
The required standard (Review system audit logs) means you must conduct regular review of system audit logs, perhaps only to find out if someone has tried to hack into your system.
Assigned access is addressable because in a small office, the receptionist may also be the billing clerk and the system administrator.
The point in each case is that the practice needs to document how they plan to comply with the standard.
18. Technology Vulnerabilities And Threats Exist Among Physician Practices
20% of medical practices are using an EHR software program
Everyone has a story.
Other 80% are stopped by costs and complexities
Local Area Network
Wide Area Network
Local Wireless
Wide Area Wireless
Client-Server
ASP
19. Basic Network - usually wired
Hospital Information System
Hospital Lab
Outside Lab
Radiology / Pathology Labs
Pharmacy
Practice Management System
Document Management
20. Wireless and peripherals
Local Wireless
Wide Area Wireless
PDAs
cell phone access
web access
PDA sync model
21. Conducting A Security Impact Analysis In a Clinical Setting
Database server
Physically secure
Locked
Backup process secure
Backup media secure
Storage capacity sufficient
Administrator Password Protected
Database Password Protected
Clients
Fat clients with data
PDAs, unsynced
Places where charts are left
Computer workstations
Printers
Scanners
22. Data Transmission 1
Wired Wireless
LAN Wireless
Server -- access point -- wireless receiver
LAN Wired
Server – fat client
23. Data Transmission 2
Practice Management System (PMS)
Document Management System
24. Data Transmission 3
WAN, Wired
server – HIS
HIS – server
server – LIS
LIS – server
server – Radiology / Pathology lab
Pharmacy
server – pharmacy info system
fax
25. PDAs
PDA, wireless
PDA, synced
Prescribing, CPOE, Notes
Hospital, Home Health
26. Internet Access
By providers
By patients
Policy, restrictions
Email to transmit information
Secure methods
27. Paper to electronic records
Scanning
Printing
Faxing
Mailing
28. Printed clinical documents
Prescriptions
Patient Instructions
Histories
Clinical Notes
Referrals
School forms
Insurance forms
Work-related forms
Reports
29. Best Practices in Risk Reduction 1
Have a Plan
Written Plans
Risk Assessment
Database backup
Database secure storage
Data restore plan
Disaster recovery plan
Software Inventory
Hardware Inventory
Logs - transmission points
30. Best Practices in Risk Reduction 2 Staff
Security Committee
Medical staff
IT staff
Training
Communication
31. Training Locking up
Backup
Log in
Password Management
Virus Protection
Malware Protection
Internet access
32. Thank you
Carolyn Hartley
Carolyn@physiciansehr.com