Confidentiality between doctor and patient has always been a given in the United States, and it’s something we have long taken for granted. However, that confidentiality isn’t as airtight as many may think. On the contrary, pharmacies such as CVS and Express Scripts have been selling anonymous prescription information to data mining companies for years. Why? It’s an effort to target advertisements to patient’s prescriptions and health conditions. The process is called matchback, and it has rightfully raised concerns about federal medical privacy laws.
How ‘Anonymous’ is It?
Matchback is allowed because the names of the patients are said to be concealed, though to many, that doesn’t justify the breach of confidentiality. IMS Health Holdings and other data brokers have collected prescription records numbering in the hundreds of millions, and they say the names of the patients are replaced by unique codes that are generated using algorithms. But, opponents of the practice are concerned that such technological advances undermine privacy laws, specifically the Health Insurance Portability and Accountability Act (HIPAA).
Confidentiality and Transparent Disclosure Concerns
While advocates of the matchback process claim that patient’s names are not directly connected to the prescription information, not all pharmaceutical companies are comfortable with it. For example, industry giant, GlaxoSmithKlinePlc, stopped engaging in the practice after its leadership became concerned about the potential for violating consumer privacy, and because not all websites were notifying users. The company’s legitimate concerns about transparent disclosure for internet users and breeches of confidentiality are at odds with other pharmaceutical companies, like Sanofi, that do use matchback to target consumers.
Money to be Made
Not all internet giants are on board with the selling of ‘anonymous’ prescription records though. Like SmithGlaxoKlinePlc, Facebook, Google and Microsoft don’t use matchbacks in their ad targeting strategies either. Perhaps the money to be made just isn’t worth the risk to them, especially given the breaches of information that occur. Opponents of matchback point to such breeches as evidence that long term tracking poses a risk to patient privacy regardless of how the data is presented, or who is in control of it.
Whether or not the mining of prescription data is legal, many believe that it is unethical. Opponents of the process argue that all health records should be kept confidential. Regardless of whether there is a name or random number attached to it, they claim, medical information is too personal to expose to any level of risk.
Medical professionals usually strive to provide the very best medical care to patients. They want to administer the right tests, prescribe the right medications, and perform needed surgeries flawlessly.
But humans make mistakes despite best intentions, including doctors and nurses. Sometimes those mistakes are the result of carelessness and actions that fall short of the accepted standards of medical care.
Patients injured as a result of medical mistakes have the right under the law to seek monetary compensation for their injuries, including medical bills, lost wages, and pain and suffering. This legal right undoubtedly helps to keep medical professionals accountable for their actions and provide a semblance of justice to injured patients and their loved ones.
But some states have passed laws that restrict the right of injured patients to seek compensation for medical malpractice. Despite dubious data, these laws are cast as a protection against “frivolous” lawsuits and a reduction of medical costs.
In the real world, these laws can put injured patients and their loved ones into legal limbo with little hope of recovering compensation for injuries, and – even more important – getting real answers to just went wrong.
A tragic Wisconsin story is a case in point.
A 91-year-old man died after breaking his pelvis when he fell off a table in a hospital while being prepped for a routine heart procedure, according to a recent article in the Milwaukee Journal Sentinel. Prior to falling, the gentleman was largely independent and able to get around on his own. He was the primary caretaker of his ailing 88-year-old wife of 65 years, attending to her needs in their home and transporting her around town.
Wisconsin has thrown up legal roadblocks for those seeking compensation for medical malpractice, and, perhaps just as troubling, obtaining information about details on medical incidents.
Similar to numerous other states, Wisconsin has placed a cap on the amount of pain and suffering damages an injured patient can receive in a lawsuit. The cap amounts vary from state to state, and in Wisconsin the limit is $750,000.
Another restriction facing the widow and her adult children: Under a unique Wisconsin law, only a surviving spouse and minor children can pursue a wrongful death lawsuit. Should the ailing widow pass away before the conclusion of a lawsuit, the wrongful death claim would end immediately. This increases the risk for an attorney to represent the woman, especially considering the relatively high expenses typically associated with pursuing a medical malpractice case.
In fact, this law creates an incentive for the hospital and its insurer to delay payment on the claim as well as resolution of any legal case.
Yet another law in Wisconsin impinges on the ability of the family of the deceased man to get answers to what went wrong. They still don’t know exactly how he fell off the prep table in the presence of medical personnel at the hospital, according to the Milwaukee Journal Sentinel.
The law bars patient access to confidential “incident reports” written by staff in hospitals, nursing homes and other health care providers, and from using the reports in civil or criminal cases. The law purportedly encourages medical professionals to be more forthcoming about the details of treatments and medical services provided to patients when accidents occur, with the ultimate goal of improving health care procedures.
But sunshine is the best disinfectant, right? Transparency and accountability to patients would more likely lead to improvements in medical care, rather than circling the proverbial wagons, and keeping incident reports under lock and key.
Achieving consistently outstanding health care is inarguably a goal shared by everyone. However, laws such as those in Wisconsin that limit the legal rights of injured patients do not appear to further that goal, and instead appear to favor the health care industry and insurance companies.
This article provided on behalf of Scott Gottlieb at Scott C. Gottlieb & Associates, LLP.
Medical errors continue to be one of our country’s leading causes of injury and death. Fortunately, medical device entrepreneur and Founder/CEO of Masimo Corporation, Joe Kiani, along with his patient safety group, Patient Safety Movement Foundation, is actively pursuing ways to reduce the number of medical errors resulting in injury or death.
According to the Patient Safety Movement, the number of deaths caused by medical errors now exceeds the number of deaths attributed to vehicle-related accidents, breast cancer and heart failure. An estimated 440,000 deaths and millions of injuries each year are caused by medical errors.
What Actions Are Being Taken to Reduce the Number of Medical Errors?
The Patient Safety Movement has as its goal the implementation of actionable patient safety solutions (APSS) that will bring about zero preventable deaths by 2020. Mr. Kiani is determined to take a stand against this type of medical malpractice. He vehemently believes Congress should pass a law prohibiting Medicare from reimbursing doctors and hospitals for procedures that lead to the accidental death of a patient. He also wants hospitals held accountable for their actions and is certain that transparency among medical practitioners could make a significant difference.
To further his cause, his patient safety group has been hosting an annual summit where patients, healthcare providers, medical technology companies and officials responsible for creating public policies can gather for the purpose of coming up with ideas and drafting strategies that will ultimately reduce the number of deaths caused by avoidable medical errors.
California Senator Barbara Boxer is a steadfast advocate as well. She is not only working to draw attention to the cause, but is actively taking steps to hold hospitals more accountable. The OC Register reports that Sen. Boxer has asked 283 California hospitals to provide her office with detailed information on the actions being taken to reduce on-site medical errors. She has also begun touring many hospitals in the state, including Children’s Hospital of Orange County (CHOC), in an effort to make hospital workers and the general public more aware of this widespread problem, and to initiate actions that protect patients. The University of Michigan reports it has been spearheading state efforts to create new statewide standards for children’s medicines, in an effort to dramatically reduce dosage errors.
Is Human Error Largely to Blame?
Close to 80 percent of all negative or injurious events in our healthcare system occur due to human error, the Patient Safety Movement reports. Incorrect diagnoses, improper treatment, failure to provide adequate care and medication errors are largely to blame. There are many instances, however, where it is the system itself causing problems, rather than individual doctor negligence or failures.
One of the factors that has made this growing problem worse is that although hospitals are required to report medical errors as one of the conditions of being paid by Medicare, an investigation conducted by the Department of Health and Human Services in 2012 found the majority of preventable medical errors were not being reported. Those hospitals that do report such errors often do not take the procedural actions necessary after such an incident to prevent them in the future. While some progress is being made in reducing medical errors, there are still many obstacles that must be overcome. And, according to the Patient Safety Movement’s website, “Getting to ZERO will take all of us working together – clinicians, administrators, medical technology companies, payers, government, and patients.”
Patient Safety Movement: http://patientsafetymovement.org/challenges-and-solutions/medication-errors/
Orange County Register: http://www.ocregister.com/articles/hospital-641332-medical-boxer.html
University of Michigan: http://www.uofmhealth.org/news/archive/201402/u-m-leads-state-effort-create-new-standards-kids%E2%80%99-medicine
The idea that diet can maintain good health and fight disease is an old one. For centuries, physicians and parents alike have pushed certain foods to cure the body’s ills. Jewish mothers serve chicken soup to anyone with a cold, following the famous recommendation from the 12th century Hebrew physician Maimonides (who actually said it would cure asthma and leprosy). Chinese parents add ginger to their kids’ meals, and Mexican abuelas slip a little chili into the sopa.
When it comes to cancer and other serious illnesses, though, patients are cautioned about dietary claims that a certain food will cure or slow a disease. A visit with a nutritionist is a much better idea to ensure the diet is well-rounded and includes nutrients to strengthen weakened immune systems.
Derivative of a Popular Indian Spice May Slow Mesothelioma
But now, researchers in U.S. and German universities say curcumin, which comes from the spice turmeric, contains a peptide that slows the progression of mesothelioma. Asbestos exposure is the only known cause of mesothelioma. Mesothelioma attorney Joseph Belluck says that any medical breakthrough is important when it comes to cancer. Although we don’t have a cure for mesothelioma, we have new information studied by doctors, such as the study of turmeric.
Turmeric is used throughout Asia and is prominent in Indian food. At this point, though, evidence that consuming it will slow the disease is thin at best. But can it be restructured for this, perhaps in a future medication?
Mesothelioma and other cancers are often triggered by the protein and transcription factor STAT3, which sends messages to start and continue the cancer’s growth. PIAS3, a protein inhibitor, or peptide, is a very effective agent against STAT3. And, according to researchers, it is found in curcumin. “We must develop a curcumin analog that is absorbable by the human body,” Afshin Dowlati, MD, Professor of Medicine at Case Western Reserve University School of Medicine, Science Daily reports. “Currently, curcumin ingested as the spice turmeric has practically no absorption within the gut.”
High PIAS3 Tramples STAT3, Kills Mesothelioma Cells
Dowlati, who is the senior author of a report that will be published October 10 in Clinical Cancer Research, and colleagues at Georg-Speyer Haus in Frankfurt, Germany, looked at tissue samples from mesothelioma solid tumors removed from patients in different parts of the US. Each sample contained information about how long the patient lived with the disease and the type of mesothelioma.
Patients with low PIAS3 peptides had active STAT3 and were more likely to die sooner. But those with high PIAS3 levels were 44 percent more likely to live another year, “which is substantial,” Dowlati says in a Case Western press release.
The researchers conclude that curcumin and PIAS3 peptides raised PIAS3 levels, which lowered STAT3 activity and caused mesothelioma cells to die, a finding that can lead to clinical trials.
PIAS3 May Hold Clues to Mesothelioma Progression
The study also shows that PIAS3 may be a reliable indicator of mesothelioma progression. Mesothelioma tumors rarely progress the same way as other ones, making it hard to predict what twists and turns patients and physicians can anticipate.
“PIAS3 activation could become a therapeutic strategy,” Dowlati theorizes. “Our findings beg the question of what role [it] could play in limiting STAT3 activation in other cancers as well.”
The New Jersey Supreme Court recently ruled that a hospital involved in a medical malpractice case did not have to turn over the results of its internal investigation concerning an infant’s brain injury during delivery.
The court’s Sept. 29 decision could potentially impact other medical malpractice cases across the country, including in Indiana.
The baby’s parents demanded access to internal documents spelling out mistakes that were made that led to the baby suffering seizure disorder in May 2007. However, the court upheld the confidentiality claim of Valley Hospital in Ridgewood, N.J.
A trial court judge had previously ruled in favor of the hospital, according to an NJ.com article published Sept. 30, on the basis that the internal memos were protected under a 2004 law known as the Patient Safety Act. The law allows hospital personnel to freely discuss mistakes without fear of recrimination in an effort to prevent errors from recurring.
The parents’ medical malpractice attorneys appealed the trial court judge’s decision. They argued on appeal that the hospital was not protected under the Act because it had not performed its internal investigation in accordance with rules the state health department enacted in 2008.
Valley Hospital argued that it could not be in violation of a rule that wasn’t in effect at the time the 2007 investigation took place. That argument ultimately proved successful.
Supporters of the Act told the website they believed the New Jersey Supreme Court made the right decision. They said the law was never intended to protect doctors and hospitals from liability. Patients and family members are still able to subpoena other types of records, and can also attempt to compel doctors and other professionals who participate in confidential investigations to testify in medical malpractice cases.
Medical Malpractice in Indiana
The Indiana Medical Malpractice Act specifies that a panel of healthcare professionals must review any sort of malpractice claim before it can be filed in court. The panel issues an opinion on whether enough evidence exists to show that either the medical facility or its staff members did not provide the correct standard of care. Once the report is filed, it can be admitted in court but it is not binding.
Indiana’s Hospital Medical Error Reporting Rule states that hospitals are required to implement a process that details the occurrence of several types of “reportable events.” These include surgery performed on the wrong body part or the wrong patient, death or disability due to contaminated drugs or devices, and many others. These reports, according to the rule, “shall be used by the department for purposes of public reporting the type and number of reportable events occurring within each hospital.”
The Indiana Code states that medical staff committee members conducting retrospective reviews are immune from civil liability in regard to their deliberations. (Section 16-21-2-8.) However, confidential records and proceedings “may be produced on court order in a cause in which the records and proceedings are relevant or material.”
It remains to be seen what effect, if any, the New Jersey ruling will have on medical malpractice cases in Indiana and throughout the country.
Additive manufacturing, or 3D printing, as it is more commonly known, is being used to produce everything from food to guns to jewelry and clothing. If that isn’t incredible enough, the medical community has been using 3D technology to manufacture human body parts, including skulls, spinal inserts, and other bones, as well as facial prostheses and breast implants for cancer patients. Human organs are even on the horizon, and that could mean the end of organ donor waiting lists. Welcome to the future of medicine.
The obvious advantage to using 3D technology to print human bone replacements is that the procedure itself allows for the bone’s internal structure to be mimicked in a way that makes the replacement part as resilient and light as the original. The bone can can also be printed to perfectly match the break. Additionally, since 3D body parts that are made from titanium or the patient’s own cell tissue will not cause adverse allergic reactions, they will not be rejected by the body. This technology is being used in hospitals and research centers around the world, from Italy to the Netherlands, and the Walter Reed National Military Medical Center in Bethesda, Maryland even has its own 3-D Medical Applications Center devoted to everything from orthopedics to dentistry and craniofacial reconstruction.
As recently as 2012, spinal implants were in the clinical trial stage at Peking University in Beijing where surgeons implanted 3D-printed titanium spinal implants into 50 patients. One year later, team leader, Dr. Liu Zhongjun, reported that all of their trial patients had recovered well with no “undesirable side effects or adverse reactions”, according to an article posted at www.engineering.com. Fast forward to August 2014 and Dr. Zhongjun and his team have successfully implanted the first 3D-printed spine vertebrae into a 12-yr old boy suffering from Ewing’s sarcoma, a type of rare bone cancer. Medical advancements have sure come a long way, but researchers aren’t finished yet.
In April 2013, Organovo, a company that designs “functional human tissue”, produced 3D human liver tissue that retained its function for more than five days. Just six months later, in October 2013, Organovo issued a press release indicating that they were able to extend that timeframe to 40 days. In a period of only six months, Organovo increased the functional longevity of their 3D-printed liver tissue by an astonishing 800%.
Researchers from Harvard University and Sydney, Australia have collaborated on a medical breakthrough that just may lead the way toward the printing of fully functional 3D organs. They have developed nutrient and oxygen-delivering capillaries using the 3D printing process. These tiny vessels allow 3D organs to excrete waste, which, along with the nutrients and oxygen, will allow the organ cells to grow and thrive. Researchers believe that full-sized, fully functioning human organs may be years away from being a reality, however, given the accelerated pace of the research done by Organovo, Harvard and Sydney, among others, the timetable may be overly cautious.
Organ donor lists may one day be a thing of the past, which is lifesaving news for the more than 100,000 people who are on the list at any given time in the United States alone. What researchers have been able to accomplish already, though, is astonishing. 3D printed body parts is a futuristic concept that may leave some people feeling a bit uneasy. However, for those whose health and lives have and will be positively impacted, the future of medicine couldn’t have come soon enough.
When an airplane crashes, the rush is on to find the black box. This is a recording device that can help investigators piece together what happened to cause the accident. A similar device recently was developed for use in the operating room. The researchers behind the device hope it prevents medical malpractice and improves patient outcomes much in the same way it aids in airline safety and accident investigations.
Reducing the rate of surgical errors is an important cause. A 2012 study from Johns Hopkins University found that such mistakes, known as “never events”, happen at least 4,000 times each year. These mistakes include wrong site surgeries, performing the wrong procedure and leaving foreign objects behind in a patient. By helping medical professionals to understand why these seemingly simple mistakes happen, a black box could help surgeons reduce their occurrence.
Black Box Prototype Tested at Three Hospitals
HealthCanal.com reports that Dr. Teodor Grancharov, who specializes in minimally invasive surgical procedures, developed the box where he works at St. Michael’s Hospital in Toronto. Up to this point, the device has been tested at the facility and two additional hospitals in Denmark.
It is about the size of a cable box. The device records everything that goes on in the operating room much like a black box on an airplane records everything that goes on in the cockpit.
The device captures any video from scopes inserted into the body. It also captures the room temperature, patient vitals, decibel levels and conversations among different healthcare workers in the operating room.
For now, the device works only for minimally invasive procedures such as those using small laparoscopic incisions. However, the hope is that its use will be expanded to a wider range of surgical procedures.
The goal is to have a documented account of everything that takes place during a surgery. Understanding where errors happen can help doctors and hospitals prevent additional mistakes and develop training and education.
Dr. Grantcharov says that developers of the black box are looking for performance issues. For example, did a surgeon apply an incorrect technique during an operation? They are also looking at “less tangible” factors that can contribute to surgical errors such as miscommunication between members of the operating team.
In addition to providing surgeons and hospital officials with information on how to improve patient safety, such devices could give medical malpractice victims important evidence of negligence if a mistake results in serious personal harm.
Your Role in Preventing Surgical Errors
While the development of a black box for surgical procedures is a promising advance in patient safety, it may be a long time before such a device is widely used and its benefits are realized in terms of preventing surgical errors.
For now, if you are undergoing surgery, you can take steps to help protect yourself. The Joint Commission (pdf), an organization that accredits healthcare agencies and promotes patient safety, offers the following tips for patients:
- Ask your doctor detailed questions about the surgery before it occurs.
- Ask for detailed pre-op instructions regarding meals, water, medications, make-up, nail trimming and other preparations you should make before the day of surgery.
- Write down any questions you may have as you prepare for surgery.
- Bring someone you trust with you on your operation day and tell them your concerns as they will be your advocate if you are unable to speak or communicate.
- Make sure all information on consent forms is correct before signing them. Ask questions if you have any before you sign the forms.
- Make sure markings put on your body for the surgery are in the right place.
- Ask your surgeon if the team will take a “time out” before your operation.
The outcome of a surgery may not be your responsibility but rather that of the surgeon and team attending to you. Still, speak up if you have questions and hold your healthcare providers accountable for any errors or problems you may experience.
Submitted by Powers & Santola, LLP
The Dangers of Food Poisoning
Food poisoning is very common and happens to people not only here in the US but throughout the entire world. Depending on the type of food poisoning one gets, people even die from it.
There are more than 250 diseases that can cause this type of poisoning but the most common cause is simple bacteria. Here is a look at some of the most common ones.
This bacteria causes one to have acute and sometimes bloody diarrhea, abdominal cramping or pain, nausea, vomiting, fever and malaise. People get this bacteria from contaminated food, milk that is not pasteurized and from pets or other animals. More serious conditions such as nerve and brain problems as well as arthritis have occurred after the initial symptoms. This is rare though.
Salmonella is another bacterial infection but we here about this one more often. It generally comes from eating raw or undercooked poultry products or unpasteurized milk but sometimes it can also come from the people preparing the food. Any time food is prepared on the same surfaces that uncooked poultry has been prepared on without the surface having been sterilized first may become tainted with Salmonella.
Some of the symptoms of this type of food poisoning are fever, diarrhea, abdominal pain, nausea and sometimes vomiting although there are cases where people become carriers but not sick. Salmonella poisoning can also result in a condition called Reiter’s Syndrome which can have symptoms such as pain in the joints, irritation to the eyes and painful urination.
Shigella is one of the more nasty bacteria as it comes from feces. This is why washing your hands after using the restroom is so very important. Symptoms of this type of food poisoning include fever, bloody diarrhea, vomiting, nausea and cramps.
E. coli O157:H7
This is another one that we frequently hear about. According to WebMD each year there are roughly 73,000 cases of this type of food poisoning each year in the US. Causes for this bacteria are things like beef that is not fully cooked or milk that has not been pasteurized. If someone swims in or drinks water that has been contaminated by sewage they can get this type of poisoning.
E. coli poisoning can present as abdominal cramps and bloody diarrhea but also non-bloody diarrhea is present. Infected people may have a fever too. Alternately, there may be not any symptoms at all.
Very rarely this type of food poisoning leads to a condition called Hemolytic Uremic Syndrome which is a medical emergency. This condition causes the red blood cells to be killed as well as kidney failure. It can cause death if not treated promptly.
Food poisoning is something that can and probably will affect most of us at least once whether we exhibit symptoms or not. Most of the time, the effects will go away on their own within 3 – 5 days. If it is a serious case, then there may be lasting effects and even death. If you think you have gotten food poisoning, see a doctor now.