HHS Delays Enforcement of HITECH Act Business Associate Provisions

We understand that yesterday Adam H. Greene (Office of the General Counsel, Civil Rights Division, U.S. Department of Health & Human Services), speaking at the ABA’s 11th Annual Conference on Emerging Issues in Healthcare Law, indicated that enforcement of the business associate provisions of the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”), which became effective on February 17, 2010, will be delayed until final rules addressing those provisions are published.  The HITECH Act’s business associate provisions require business associates to implement the information security safeguards specified by the HIPAA Security Rule, and comply with certain requirements of the HIPAA Privacy Rule.  Similarly, the HITECH Act requires covered entities to provide in their business associate agreements that all of the HITECH Act’s security requirements applicable to covered entities are also applicable to business associates.

The Office for Civil Rights (“OCR”), which enforces HIPAA’s Privacy and Security Rules, has stated publicly that it is carefully evaluating how to proceed with HIPAA enforcement.  For example, Section 13411 of the HITECH Act requires HHS to “provide for periodic audits to ensure that covered entities and business associates” are complying with the HITECH Act and its implementing regulations.  At the 18th Annual National HIPAA Summit in early February, Sue McAndrew, the OCR’s Deputy Director for Health Information Privacy, explained that there are “1,000 ways” to conduct HIPAA audits and that OCR is working with a HIPAA expert to “map out essentially the range of options” to determine how best to effectively conduct HIPAA audits.

Despite the delay in enforcement, covered entities and business associates should take necessary actions to comply with the HITECH Act’s requirements.  Please see our client alert on HITECH compliance for more information.

First Amendment Challenge Prompts Maine AG to Postpone Enforcement of New Child Privacy Protection Law

On September 9, 2009, the U.S. District Court for the District of Maine dismissed a lawsuit challenging the validity of the Act to Prevent Predatory Marketing Practices Against Minors (the “Act”), which is set to take effect on September 12, 2009.  The Act prohibits businesses from knowingly collecting or receiving a minor’s health-related information or personal information for marketing purposes without first obtaining verifiable parental consent.  Businesses are also prohibited from using any health-related information or personal information regarding a minor for the purpose of marketing a product or service to the minor.  In dismissing the claim, the Court acknowledged that the Plaintiffs had successfully established the likelihood of success on the merits that the Act is overbroad and violates the First Amendment.  Although the Plaintiffs met this burden, the Court recognized that the Attorney General has agreed not to enforce the Act, and the Maine Legislature is committed to reconsidering its scope in January 2010.  Accordingly, the Court, with the agreement of the parties, closed the lawsuit in a stipulated order of dismissal.

Click here for details regarding the scope and requirements of the Act.

Maine Enacts Comprehensive New Law Restricting Marketing to Minors

On September 12, 2009, Maine’s Act to Prevent Predatory Marketing Practices Against Minors (the “Act”) will take effect.  The Act prohibits businesses from knowingly collecting or receiving a minor’s health-related information or personal information for marketing purposes without first obtaining verifiable parental consent.  Businesses are also prohibited from using any health-related information or personal information regarding a minor for the purpose of marketing a product or service to the minor.  Pursuant to the Act, the use of information in such a manner is a predatory marketing practice, which may be sanctioned as an unfair trade practice.  The law also allows individuals subject to unlawful data collection or predatory marketing practices to bring a private right of action against violators.

For businesses, the implications of Maine's new data collection and marketing restrictions are far-reaching.  The scope of the law covers both online and off-line marketing activities, and the broad definition of personal information includes a minor’s name in combination with any information concerning the minor.  In light of the Act’s restrictive requirements and considerable scope, businesses would be well-advised to evaluate their current marketing practices and age verification mechanisms.  The text of the law is available here.