February 2013

Improving Healthcare Quality: Electronic Prescribing

February 26, 2013
Healthcare, Healthcare Reform, Pharmaceuticals

by Johanna Smith, UMN Law Student, MJLSTStaff

A new study published online on February 20, 2013 in the Journal of the American Medical Informatics Association found that when hospitals used electronic prescribing, it prevented 17 million drug errors–and if implemented more widely and consistently, it could prevent more than 50 million drug errors. But as of 2008, only about one in three acute care hospitals used electronic prescribing. Although there are various methods suggested to improve healthcare quality, one of the simplest is to make medical errors public. If hospitals, and the general public, were more aware of the safety benefits of electronic prescribing, this could lead to increased use and standardization. Another option to increase the use of electronic prescribing is to connect funding or reimbursement to the use of electronic prescribing.

An article in the January 23, 2013 Journal of the American Medical Association reported that once Medicare and Medicaid stopped reimbursing costs due to certain medical errors, the number of times a foreign item was left in a surgical patient dropped by half. The authors note that this number may not be truly accurate, since the hospitals would have financial incentives to hide the errors. Currently, reporting relies mainly on self-reporting by the hospitals, which is not always accurate. A new article in the Minnesota Journal of Law, Science, and Technology (MJLST) by John R. Grout, John W. Hill, and Arlen W. Langvart entitled “Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications,” discusses how to mistake-proof medicine and looks at healthcare quality on a broader level, including electronic prescribing. The MJLST article highlights that many hospital administrators are concerned more with the finances of the hospital than with patient safety. Connecting these two items increases the probability that patient safety will become a priority for hospitals. Although electronic prescribing is not a complete fix for incorrect prescriptions, it is an important part of improving the process. Compared to the cost of medical errors–including incorrect prescriptions–mistake-proofing is generally less expensive.

And the Patent Goes To…… The First to File

February 19, 2013
Patents

by Emily Puchalski, UMN Law Student, MJLST Notes & Comments Editor

In just about one month the most monumental provision of the America Invents Act (AIA) will take effect. As of March 16, 2013 patents will be awarded to the first to file rather than the first to invent. This first to file system will bring the United States in accord with many other countries of the world. However, it is important note that the first to invent rule will still apply to patent applications filed before March 16th 2013.

Many patent lawyers and their clients have already began thinking about what the first to file system will mean for the American patent system. For example, a group of patent attorneys have already outlined some strategies that could be employed by inventors and predictions for how the new system will operate. Patent lawyers are not the only ones thinking about what the new systems will look like. Universities, for example, which can derive significant revenues from the patented inventions of its faculty, have implemented strategies for dealing with the new system. The University of North Dakota, for example, has stressed that the changes in the law as of March 16th govern towards immediate disclosure of any invention to the school’s intellectual property office to make sure that it can obtain patent rights on the invention, if desired, by filing an application as soon as possible with the Patent and Trademark Office.

Despite the prominence of the first to file provision of the AIA, it is important to remember that the AIA has many other important provisions aimed at changing the American patent law system. The AIA has also significantly changed the review available after a patent has been granted. The AIA both strengthens existing review procedures and creates new ones as well. In her article published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology, “The Post-Grant Problem: America Invents Falling Short,” author Kayla Fossen provides an in-depth description of the post-grant review process under the America Invents Act. Fossen also takes a look at whether the new post-grant proceedings can effectuate change on the American patent system where patents are frequently invalidated in infringement litigation. Interestingly, Fossen proposes a pre-grant review process that could be used in addition to the post-grant proceedings under the America Invents Act to ensure that patents issued are strong enough to survive validity challenges in any infringement litigation. Even though March 16, 2013 will mark a big change in US patent law, it is important to evaluate the big changes that the America Invents Act has already made, one of them being post-grant review. Luckily, Fossen’s article does just that.

Time for a New Approach to Cyber Security?

February 18, 2013
Cyber Security, Internet, Law Enforecement

by Kenzie Johnson, UMN Law Student, MJLST Managing Editor

The recent announcements by several large news outlets including the New York Times, Washington Post, Bloomberg News, and the Wall Street Journal reporting that they have been the victims of cyber-attacks have yet again brought cyber security into the news. These attacks reportedly all originated in China and were aimed at monitoring news reporting of Chinese issues. In particular, the New York Times announced that Chinese hackers persistently attacked their servers for a period of four months and obtained passwords for reporters and other Times employees. The Times reported that the commencement of the attack coincided with a story it published regarding mass amounts of wealth accumulated by the family of Chinese Prime Minister Wen Jiabao.

It is not only western news outlets that are the targets of recent cyber-attacks. Within the past weeks, the United States Department of Energy and Federal Reserve both announced that hackers had recently penetrated their servers and acquired sensitive information.

This string of high-profile cyber-attacks raises the need for an improved legal and response structure to deal with the growing threat of cyber-attacks. In the forthcoming Winter 2013 issue of Minnesota Journal of Law, Science, and Technology, Susan W. Brenner discusses these issues in an article entitled “Cyber-Threats and the Limits of Bureaucratic Control.” Brenner discusses the nature, causes, and consequences of cyber-threats if left unchecked. Brenner also analyzes alternative approaches to the United States’ current cyber-threat control regime, criticizes current proposals for improvements to the current regime, and proposes alternative approaches. As illustrated by these recent cyber-attacks, analysis of these issues is becoming more important to protect sensitive government data as well as private entities from cyber-threats.

States Move to Implement Health Insurance Exchanges

February 13, 2013
Healthcare Reform, Public Health

by Brianna Rohne, UMN Law Student, MJLST Articles Editor

Proponents of the Affordable Care Act breathed a collective sigh of relief in June 2012 when the U.S. Supreme Court upheld most of the law in its decision in National Federation of Independent Business v. Sebelius. As Minnesota Lawyer reports, the health care law will have a major impact in 2013 as state and federal agencies rush to implement the ACA’s key features.

Chief among those features are the Health Insurance Exchanges, which are insurance marketplaces designed to help carry out the ACA’s key feature–the individual mandate–by simplifying the process for purchasing health insurance for consumers and small businesses in every state. As Kathleen Sebelius comments, the Exchanges will provide “one stop shopping for health insurance with better information about plan benefits, quality and cost.” The Exchanges, which will be administered at the state level, must be ready for open enrollment in October 2013 and full operation on January 1, 2014.

Department of Health and Human Services rulemaking has stressed flexibility in the creation and operation of the Exchanges, encouraging each state to take the lead in shaping their Exchange in a way that best accommodates local needs and market conditions. For example, states may choose the type of entity to operate the Exchange, limit the insurance plans eligible to participate, and partner with other states to establish regional Exchanges. HHS also offers support in the way of formal partnership, grant funding, technical assistance, and guidance on key topics.

HHS also allows states to opt out of Exchange planning altogether, leaving it up to the federal government to implement Exchanges in those states. As of early January, the New York Times reported that 23 mostly Republican-run states had indicated that they will not set up their own Exchanges. Another 17 states and the District of Columbia are moving to set up their own Exchanges and seven states have asked to collaborate with the federal government.

Ensuring health coverage and subsequently affordable health care for millions of uninsured and under-insured Americans is an ambitious undertaking, fraught with challenges that states and the federal government are just beginning to work through. In a recently published article from the current issue of the Minnesota Journal of Law, Science and Technology titled Developing a Durable Right to Health Care, Erin C. Fuse Brown discusses the momentous shift in policy accomplished by the ACA’s statutory right to health care. She goes on to warn that the ACA’s right to health care is fragile–especially early in its lifespan–and faces significant political and market challenges. Ultimately, the success or failure of the ACA’s most ambitious goals may become apparent as the federal government and states begin its roll-out over the next few years.

Chimeras in DNA Forensic Testing: What to do?

February 13, 2013
Criminal Law, DNA Evidence, Forensic Evidence, Forensics

by Ryan J. Connell, UMN Law Student, MJLST Staff

The answer as suggested in an essay titled Chimeric Criminals by David H. Kaye in the current issue of the Minnesota Journal of Law, Science and Technology is not to worry about it too much.

The article criticizes the book Genetic Justice: DNA Databanks, Criminal Investigations, and Civil Liberties by Sheldon Krimsky and Tania Simoncelli. The book has latched on to a particular genetic anomaly referred to as chimerism. Chimerism denotes the presence of two genetically distinct cell lines in the human body. The authors of Genetic Justice want to use this rare condition to show that the supposed assumption that DNA profiling is infallible is incorrect.

Think for a moment about what DNA evidence has done in criminal law. Do not just think of the convictions, but think of the acquittals, and think of those freed from incarceration by innocence projects around the country that can be attributed to the use of DNA evidence. To call DNA evidence into question over such a rare and insignificant condition such a chimerism stretches the confines of reasonableness. Genetic Justice proffers that there is a 1/2400, 1/10, 1/8, and 1/1 incidence of chimerism. Other estimates are no better. A 2010 article in the Globe and Mail entitled “The Dark Side of DNA” called DNA evidence into question and offered that chimerism may be present in anywhere from a tiny population to ten percent of the population. If an entire science is going to be called into question some better statistics might be advisable first.

This book and other sources, such as “Expert evidence: the genetic chimerism and its implications for the world of law” by Daniel Bezerra Bevenuto assume that if genetic evidence is gathered and then does not match the defendant’s DNA that the courts and lawyers will simply dismiss the case. I think courts can handle whatever problems chimerism presents. If DNA is recovered at a crime scene and identifies person X and said person is chimeric and the reference sample he provides doesn’t match the sample recovered at the crime scene the court will rightly be concerned. The natural and simple remedy to this solution is just to test again. Normally chimeric cells are isolated so a second reference sample taken from the suspect should resolve the anomaly.

Chimerism does not preset the problem that the authors of Genetic Justice suggest. It is a rare occurrence that a DNA sample recovered at a crime scene doesn’t match the DNA of the suspect it identifies. And even in those rare circumstances where the DNA doesn’t match it is an easy fix. For a more detailed analysis of this issue please read the article by David H. Kaye in the Minnesota Journal of Law Science and Technology.

The full issue of MJLST in which David Kaye’s article appears can be found here.

February 2013

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