Tag: Health
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 »
Long-Awaited HIPAA and HITECH Final Rule Released
A final omnibus rule has been released by the Department of Health and Human Services. The final rule makes changes to the Health Insurance Portability and Accountability Act (HIPAA) regulations related to privacy and security. The final rule, in its entirety, can be found here.
Check back soon for a response from our life sciences team.
Follow continued coverage from our Government & Regulatory Affairs colleagues here.
Where to Spend Your Healthcare Investment Dollars
In a blog entry written over the summer, I expressed the view that the next 5-10 years will present tremendous transactional opportunities in the life sciences/health care industry. Nothing has happened to dampen that view. In fact, President Obama’s reelection, which means that the Patient Protection and Affordable Care Act is here to stay and will be fully implemented over the next few years, and our ongoing deficit reduction concerns, mandate that efficiency, cost control and strategic ways to provide better quality healthcare will be at center stage. So let’s focus in on some investment opportunities that may be interesting.
For those willing to tackle regulatory and reimbursement hurdles, there should be many opportunities in the provider world. This could take the form of hospital mergers and consolidations, spin-off of various medical and lab services that have been provided at hospitals and … 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 »
New post from Capitol Health Record on call for more new medicines from Presdient’s Council of Advisors on Science & Technology
Published by Capitol Health Record on October 3, 2012
Written by: Amy Walker
Last week, the President’s Council of Advisors on Science and Technology (PCAST) released their “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.” The report recommends that the United States set a goal of doubling the number of new medicines “that meet critical public health needs” over the next ten to 15 years.
PCAST, which was formed in April 2009 by President Barack Obama, is an advisory group consisting of leading scientists and engineers which makes science and technology policy recommendations to the President and the Executive Office of the President.
For the report, PCAST analyzed trends and challenges in biomedical research and development over recent years, finding that scientists need better methodologies and tools for translating discoveries and pharmaceutical developers and regulators need to incorporate efficiencies … 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 »
House Bill Introduced on Clinical Trial Database Registry
On August 2nd, H.R. 6272, the “Trial and Experimental Studies Transparency (TEST) Act of 2012” was introduced in the House. TEST would amend the Public Health Service Act to expand the clinical trial registry data bank. Among other requirements, the bill would require all foreign clinical studies to meet the same requirements as domestic trials (if used to support an application for U.S. marketing).
Also, the bill would require that results from most covered trials be posted on the registry data bank within one year of the “primary completion date” of the trial. Delayed submission of results up to two years after trial completion would be allowed for trials on drugs of devices that have no previous history of approval for use. The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) would be instructed to provide Congress … Read More »
Tremendous Transactional Opportunities
For deal junkies, the next 5-10 years should be quite interesting in the life sciences/health care industry. We have already seen large pharmaceutical company consolidations, financial buyers investing in health care institutions and partnerships between payors and providers. And much of this before the Supreme Court decided that health care reform is here to stay.
What is driving this? Need, opportunity, cash and innovation. Pharmaceutical company brand drugs are losing their patent protection, the cost/risk of developing new drugs is enormous, heath care costs need to be controlled, people are living longer, health care reform is triggering new behaviors and strategies and, despite the difficult financial times, there is much cash available for investment. Also, much of the broader life sciences/health care industry has been slow in technology adoption, while technology and social media continues advancing, being available to a broader … Read More »
Medical Device Security: How Safe is Wireless Technology?
The health care industry has seen a jump in the number of medical devices that use wireless technology. With this rapid technologic development comes concern about the safety, security and privacy of patients. There is specific concern in this regard with respect to the following commonly used devices: Implantable Medical Devices (IMDs), External Medical Devices, and Portable Devices.[i]
Last year a security researcher successfully demonstrated how an outside breach of a wireless insulin pump allows for the hacker to shut off or alter the settings of the device. This poses a serious risk for those with portable and implantable medical devices that are controlled via wireless technology. In addition to a breach of control of these devices, the risk of malware on such FDA-approved medical devices is also a concern. In the event that an FDA-approved medical device is infected with … Read More »