Tag: information
HIPAA/HITECH Omnibus Final Rule: Implications for Research
The Department of Health and Human Services’ HIPAA/HITECH Omnibus Final Rule (Final Rule) includes a number of provisions that will alleviate certain restrictions and administrative burdens in human subjects research and help streamline the documentation associated with research. Here are the significant changes:
Compound Authorizations
The current HIPAA Privacy Rule generally prohibits “compound authorizations,” which are authorizations for use and disclosure of protected health information (PHI) that are combined with any other legal permission. An exception to this general prohibition permits combining an authorization for use and disclosure of protected health information in a research study with any other written permission for the same study, including an informed consent to participate in the research. However, until March 26, 2013, the effective date of the Final Rule, even the same study exception is unavailable if one of the authorizations or permissions conditions treatment, … Read More »
HHS Releases HIPAA Omnibus Final Rule
On January 17, 2013, the Department of Health and Human Services (HHS) publicly released the long-awaited HIPAA Omnibus Final Rule (Final Rule). The Final Rule (1) implements many provisions of the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH Act), expanding the privacy and security standards directly governing covered entities and business associates; (2) modifies the interim final rule for Breach Notification for Unsecured Protected Health Information (Breach Notification Rule); (3) modifies the HIPAA Privacy Rule to strengthen the privacy protections for genetic information by implementing section 105 of Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA); and (4) makes certain other modifications to the HIPAA Privacy, Security and Enforcement Rules to improve their workability. Notably, the Final Rule does not address the anticipated accounting of disclosures requirements, which was the subject of … Read More »
Massachusetts Refines Its Sunshine Law; Final Federal Sunshine Regulations Moving Ahead
The relationship between health care providers and drug and device manufacturers has been a focus of lawmakers at both the federal and state level. While we continue to await final federal regulations implementing the Physician Payment Sunshine Act (federal Sunshine Act), which generally requires disclosure of financial arrangements among physicians, teaching hospitals, and drug and device manufacturers,[1] Massachusetts has refined its requirements governing relationships between physicians and drug and device manufacturers. Amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct regulations[2] (the Massachusetts Regulations) broaden the scope of permissible meals and refreshments that may be provided by manufacturers to health care practitioners and clarify issues related to preemption of the Massachusetts Regulations by the federal Sunshine Act. The Massachusetts changes and impending release of final federal regulations underscore the continuing need for drug and device manufacturers to … Read More »
The Federal Circuit’s Recent “Safe Harbor” Ruling Could Impact Biosimilars Drug Development
A recent Federal Circuit case, Momenta v. Amphastar, involves the Hatch-Waxman 271(e)(1) safe harbor, and is rousing the biologics and biosimilars industry. In particular, the court held in Momenta, that section 271(e)(1) does apply to certain post-approval activities.
As background, Momenta Pharmaceuticals, Inc. and Sandoz Inc. filed for a preliminary injunction against Amphastar Pharmaceuticals, Inc., International Medication Systems, Ltd., Watson Pharmaceuticals, Inc. and Watson Pharma, Inc. in the U.S. District Court for the District of Massachusetts alleging infringement of U.S. Patent No. 7,575,886. The ‘886 patent generally claims processes for analyzing heterogeneous populations of sulfated polysaccharides. Momenta alleged that Amphastar infringed the claimed processes when developing and manufacturing of batches of generic Lovenox (enoxaparin), a low-molecular-weight complex polysaccharide, for commercial sale. (Momenta used the claimed processes to gain approval of its own generic enoxaparin one year earlier.) The district court granted Momenta a preliminary injunction, concluding that Amphastar’s testing … Read More »
Electronic Health Records: Looking Past Skepticism
With more instances of Electronic Health Record (EHR) data breaches popping up in the news, skepticism is beginning to build as to whether or not the health care industry can handle the switch from paper to digital. In the most recent incident, The Surgeons of Lake County, located in northern Chicago, fell victim to a data breach by hackers who were able to gain access to e-mails and electronic medical records. Adding to the nation’s interest in this specific incident, the hackers have encrypted the data, holding it “hostage” for ransom from the health care facility. The hackers are demanding payment in exchange for a password that will allow doctors to regain access to their patients’ electronic health records.
Aside from data breaches, EHRs have come under fire for other kinks and flaws related to their implementation. In late July, a … Read More »
The FDA Proposes New Rule on Unique Medical Device Identification and Marking Requirements
The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages. See 77 FR 40736 (July 10, 2012). The FDA intends the unique device identification system to reduce medical errors, create greater accuracy in adverse event reporting and post-marketing surveillance, and facilitate recalls. The proposed rule, which was promulgated in accordance with the Food and Drug Amendments Act of 2007, is the result of pilot testing and public input. The UDI requirements, process, and implementation schedule are of particular interest to medical device and instrument manufacturers, and will have an impact on manufacturing and supply chain operations. Comments on the proposed rule may be submitted to the FDA by November 7, 2012.
Goals of the … Read More »
Social Medicine?
It isn’t difficult to see that the main impact of social media penetration in our culture is an epidemic of oversharing. Americans under the age of 25 have a very different approach to privacy than, say, your average 30 year-old, and feel weirdly comfortable sharing details of their private lives. E-mail is considered to be outlandishly formal, large scale sharing over social networks and texting is commonplace, and the barriers between personal and institutional communication are nearly non-existent.
This has led, predictably, to mass sharing of medical information online — even two years ago, news organizations were reporting on the rise of “e-patients” who talk to medical experts and amongst themselves in order to obtain treatment, piece of mind and/or the thrill of exposure.
Suddenly, there is widespread information about adverse outcomes and side effects, in every search that someone does for … Read More »
Massachusetts Amends Its Drug and Device Marketing Law
On July 8, Governor Deval Patrick signed a bill amending the Massachusetts law regulating marketing activities by pharmaceutical and device manufacturers, one of the strictest state laws in the country.
The law previously barred pharmaceutical and device manufacturers from providing meals to health care practitioners outside the practitioner’s office or hospital setting. See 111N Mass. Gen. Laws § 2. The amendment will now permit pharmaceutical and device manufacturers to provide modest meals and refreshments outside of the practitioner’s office or hospital setting, if the meal or refreshment is furnished with a non-CME educational presentation for the purpose of providing bona fide medical information, and the meal is furnished in a venue and manner conducive to communicating information. The amendment directs the Massachusetts Department of Public Health to promulgate regulations to define “modest meals and refreshments.” Pharmaceutical and device companies, however, will … Read More »
U.S. clinical trial website pairing — a need for privacy safeguards
Fox Trial Finder is a welcomed initiative in ongoing efforts to facilitate clinical trial participation. In a recent interview with ABC’s Diane Sawyer, Michael J. Fox, who suffers from Parkinson’s disease, said that in addition to his support for stem cell research addressing Parkinson’s, he also supports research looking for a cure on other fronts, including drug therapies and diagnostic tests. (Article Link) Toward that end, Fox’s Foundation for Parkinson’s Research recently launched an online initiative called Fox Trial Finder. This website promotes research across the country by pairing patients with clinical trials in their areas, based on the individual’s symptom profile. The foundation’s webpage notes that 30% of all clinical trials fail to recruit even one subject, and that 85% of clinical trials are delayed because of insufficient subject enrollment – so Fox’s initiative (and others like it that … Read More »
CMS’s Proposed “Sunshine” Regulations: Implications for Research
On Dec. 19, 2011, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule to implement § 6002 of the Patient Protection and Affordable Care Act (PPACA), commonly referred to as the Physician Payment Sunshine Act (Sunshine Act). The Sunshine Act was included in PPACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of federally reimbursable drugs and biologicals and covered medical devices and medical supplies, and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Proposed Rule details requirements for processing and reporting payments by pharmaceutical, device, biological and medical supply “applicable manufacturers”1 to physicians and teaching hospitals that are “covered recipients.”2 The Proposed Rule also sets forth requirements for reporting ownership and investment interests held by physicians and their immediate family members in applicable … Read More »