The Office of Civil Rights has published the new Notice of Proposed Rule Making (NPRM) related to the changes in the HIPAA Privacy and Security rules impacted by the HITECH Act. You can read the proposed rule here:
OCR Proposes New Rule
The document is 234 pages so it takes awhile to read. On a cursory read of it, here are some of the things that appear to be coming with these changes:
Make the requirements under the privacy and security rules apply to business associates just as they presently apply to covered entities.
The definition of a business associate has been modified to include subcontractors. This will be a big impact for the medical transcription industry as it will now require independent contractors who work for medical transcription services to classify themselves as a business associate, with all of the responsibilities that go with that. It clearly defines that a subcontractor, or independent contractor, will be a business associate of the business associate. Under the proposed rule, patient safety organizations now are defined as business associates.
It will require business associates obtain "satisfactory assurances" from subcontractors that they will comply with applicable requirements of the privacy and security rules. Existing contracts between business associates and subcontractors can be grandfathered for up to one year beyond the rule's compliance date. OCR estimates 1.5 million business associates may have to bring subcontractors into compliance.
Requires notice of privacy practices to include a description of the uses and disclosures of protected health information that require an authorization.
Enable individuals to request restriction of disclosures of PHI, unless otherwise required by law, if the restriction applies solely to a service fully paid out-of-pocket.
Strengthen the right of individuals to obtain their electronic health records.
Cost of Implementation
With any proposed rule making, there is a requirement that there be a cost analysis. I find this fascinating as it requires a real understanding of the industry and a lot of "guesstimates" about what will be required. The biggest costs have been identified as covered entities making new Notices of Privacy Practices, which must be rewritten and distributed to patients, and the cost of amending business associate agreements and/or writing new agreements between a business associate and their subcontractors.
The cost of redoing the notice of privacy practices is estimated at $166.1 million. The report estimates that 71% of this cost will be in the private sector and the other 29% in the government or public sector. While that sounds extremely costly and impossible to grasp, the report goes on to break the cost down per covered entity, with an estimate of $168 per covered entity. When viewed individually, it does not seem unreasonable.
It's important to note that the OCR does not have information on the cost of redoing contracts for business associates as they do not have the supporting data. While there is an estimate of 1,500,000 total business associates, no one really knows how many subcontractors each may have. That makes providing a cost estimate on this portion of the change something they are seeking information on.
How Long Will Compliance Take?
The OCR has prepared an estimated annualized burden table, which indicates what portion of the rules is referenced, the type of respondent, the number of respondents, average number of responses per respondent, average burden hours per response, and total burden hours.
This report estimates that there are 1,500,000 business associates, and allocates one hour per business associate to cover legal review of their revised business associate contract. That accounts for 1,500,000 hours of time spent to get this done. The estimated number of hours for revision of the Notice of Privacy Practices is 233,833, for an estimated 701,500 respondents. The time estimated to disseminate the new Notice of Privacy Practices for 200,000,000 patients is one hour per 100 patients, adding up to 2,000,000 hours. That makes the total estimated time 3,733,833 hours! Just in case you're wondering, that equals 155,576 days, 31,115 weeks (based on a 5-day work week), or 598 years! Thankfully all of this isn't being done by one person!
The OCR is proposing that an additional 12 months be given for full compliance, in addition to the six months they are currently allowed to give. This would give a total of 18 months for compliance with portions of the proposed rule.
Here's my question. Does this change your plans for implementation? How do you foresee that these changes will impact your business?