Final Breach Notification Rule: HHS Back to the Drawing Board

The Department of Health and Human Services (HHS) has announced that its development of a Final Breach Notification Rule (currently, the rule is in interim final form) has been stalled, as the final rule was withdrawn from consideration of the Office of Management and Budget  in order for HHS to give further consideration to what the final rule should include.  HHS has remained relatively quiet regarding the development of a Final Breach Notification Rule, but has announced that it intends for a final rule to be published "in the coming months." 

New UK Government Announces Major Healthcare Reforms

This post was written by Edward S. Miller, Eugene Tillman, Cynthia O'Donoghue and Leon Stephenson.

The new UK Coalition Government has released its much publicized White Paper "Equity and excellence: Liberating the NHS", outlining far reaching proposals to reform the health care system in the UK over the next four years.

With further consultations, reports and primary legislation promised and set out step by step in a formal structural reform plan, the detail of the proposals is currently very high level. The stated objectives are ambitious and if instituted will have a far reaching effect on both the way the British public access the health system and the role of the private sector in UK health care, increasing opportunities for involvement of private providers of both clinical and support services in the provision of health care to NHS patients.

To read the full alert, click here.

Pennsylvania Assisted Living Residences Final Regulations

This post was written by Karl A. Thallner and Amie E. Schaadt.

On July 17, 2010, the Pennsylvania Department of Public Welfare (DPW) published its final regulations for assisted living residences (ALRs) operating within the Commonwealth  40 Pa.B. 4073. The final-form regulations were drafted to fulfill the statutory requirements of Act 56, which was enacted by the Pennsylvania General Assembly on July 25, 2007 and amended the statute regulating and licensing personal care homes by creating, defining and providing for the licensing and regulation of ALRs.

DPW had published proposed ALR regulations on August 9, 2008. While much has remained the same, Act 56 and the final regulations for ALRs represent a significant change in the manner in which the Commonwealth views the continuum of care for seniors and individuals with chronic disabilities.  The final ALR regulations incorporate some significant changes from the proposed regulation and ALRs will need to comply with DPW’s new regulatory requirements.

To learn about the important differences between the proposed and final regulations, read our full alert.

New HITECH/HIPAA Proposed Rule Released Today

HHS has just released its proposed rule modifying the HIPAA Privacy, Security, and Enforcement Rules to implement the privacy, security, and certain enforcement provisions of subtitle D of the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009).  The advance version of the rule can be accessed here; the official version will be published July 14.  A press release should be available later this morning.

Pursuant to the announcement of the proposed rulemaking on the HHS Privacy website, the proposed modifications to the HIPAA Rules include provisions extending the applicability of certain of the Privacy and Security Rules’ requirements to the business associates of covered entities, establishing new limitations on the use and disclosure of protected health information for marketing and fundraising purposes, prohibiting the sale of protected health information, and expanding individuals’ rights to access their information and to obtain restrictions on certain disclosures of protected health information to health plans. In addition, the proposed rule adopts provisions designed to strengthen and expand HIPAA’s enforcement provisions.

Importantly, HHS has stated that the new HIPAA regulations will not be enforced until 180 days after the final rule has become effective. Comments will be due on or about September 13, 2010.

More to come . . . 

Reed Smith Health Care Reform Review: The Affordable Care Act - Analysis and Implications for DMEPOS Suppliers

This post was written by Debra A. McCurdy

In April 2010, Reed Smith provided an extensive analysis of the recently-enacted health reform legislation, H.R. 3590, the Patient Protection and Affordable Care Act (PPACA), as amended by H.R. 4872, the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act).  In this analysis, we concentrate on those provisions in the new law that will affect suppliers and manufacturers of durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS).

To read the full alert, click here.