Skip to main content

Tougher HIPAA Rules around HITECH

BayBiotech.NET
The Health Information Technology for Economic and Clinical Health Act ( HITECH), intended to promote adoption of information technology for maintenance of electronic health records and incorporated into the American Recovery and Reinvestment Act of 2009, was signed into law on Feb. 17, 2009. The key points of the provisions are:
1. Tracking the medical information disclosure: According to the new legislation, physicians will be required to track any disclosure of a patient's medical information. Previously regulations allowed physicians to disclose patient information for the purpose of treatment, billing or health care, but they were not required to track when that information was disclosed. This provision kicks in for current users on Jan. 1, 2014, and then patients will be able to request an accounting of disclosures of their electronic personal health information three years from the date of the request, potentially dating back to 2011.

2. Rules regarding security breaches new legislation require practices to post information about security breaches if a breach affects 10 or more patients. If a security breach affects 500 or more patients, practices must notify all of their patients, a local media outlet, and the HHS secretary. New enforcement also escalates the fines for the security breaches ranging anywhere between $100- $1.5 million.
Thus the new legislation provides more control to the patients over the handling of their health care records, but increases the costs and risks for a health care facility for protecting the health information. This will also mean that health care facilities will have to spend more resources and develop infrastructure to keep the electronic health care records secure. This regulation also opens avenues for the emergence of contract health care management facilities that can be used to outsource handling of the patient’s health care information and thus will help save resources and will keep the costs manageable for the health care facilities.
(Ref: www.hhs.gov/ocr/hipaa/)

Comments

Post a Comment

Popular posts from this blog

Amendments for High Risk Device Type Regulatory Pathway

BayBiotech.NET Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices. Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency. GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review. As a result of the report, FDA has committed to address al...
Post a Comment
Read more

What to include in Traditional 510(k) Filing for Medical Devices

BayBiotech.NET A 510k is a premarket submission made to FDA to demonstrate that a medical device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device. A Traditional 510(k) submission must include the required elements as per 21 CFR 807.87 (Information required in a premarket notification submission):  the name of device, (the trade or proprietary name), if any, and the common or usual name or classification name of the device.  description of the device, include device specifications and reference applicable guidance documents, special controls, or standards; photographs or engineering drawings should be supplied, if applicable.  comparison with a predicate device(s), indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operatio...
Post a Comment
Read more

Harmonization by Doing (HBD): Japan & U.S. Collaboration

BayBiotech.NET HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals. To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan. The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/M...
Post a Comment
Read more