Monday, June 19, 2017

HCSI Interview with Hunter Howard of Hormone Therapeutics Episode: 22

In this show, Lance King of Healthcare Compliance Solutions ( interviewed Hunter Howard, president of Hormone Therapeutics.

Hunter Howard
Personal Life
Hunter Howard is the president of Hormone Therapeutics. This is the third health tech company he's started. He loves to travel and has been to 97 countries. Hunter believes that experiencing new things is what life is all about. He spoke about a couple of his travel experiences in the interview. He loves entrepreneurs, seekers, people who do new things. Hunter considers himself a foodie and is currently writing book about the best dining around the world. He got his recommendations from hundreds of company presidents. The book will be called “Where the Presidents Eat.”  When Hunter was younger he was a passionate sports fan and wanted to go into sports marketing. When he went to business school, he saw new opportunities and followed the entrepreneurial path, instead.
Hunter believes in being a lifetime learner. After he sold his first company, MediGain, he should have been feeling relaxed and happy but he felt awful. He knew there was something wrong. Hunter spent the next year of his life going to doctors to figure out the problem. He found he had low testosterone and late onset food allergies. Once he had the tests and discovered the problems, they were easy to fix. His doctors kept wanting to give him medications and didn't want to do the tests. At that point, Hunter realized the opportunity in the healthcare market for a someone who specialized in doing wellness programs based on various blood tests. Hunter's current passion is for helping people live their healthiest life through wellness, instead of following the sick care model.  (A few of our other interviewees spoke of this same passion and the need for the healthcare industry to make the move from sick care to wellness support here, here, here, and here.)

Hormone Therapeutics
This passion has helped Hunter create his current company, Hormone Therapeutics, a company that focuses on improving healthspan, meaning helping people be healthy throughout their entire lives. Hormone Therapeutics follows the telemedicine model and utilizes blood testing kits to measure wellness in clients. If people live outside of New York or LA, or other major metropolitan area, they can't find hormone replacement therapy experts in their local areas. To reach more people, the company devised a long-distance solution. Hormone Therapeutics will send a kit through the mail  and set someone up with a teleconsultation (or if a client prefers, a nurse can bring a kit to any home in America). The team will start with genetic testing to figure out eat, sleep, and exercise profile if the individual. Next, the team will test a person's endocrine system and figure out medication metabolism. Gut bacteria is linked to physical and mental health, so Hormone Therapeutics will also figure out a client's biome.
 One of the tests performed measures telomeres, which are the ends of a piece of DNA. Every time genes split, the telomeres get shorter. A cellular age can be established with the telomere test. A qualitative self-evaluation is also taken. All of these tests can tell you where you are deficient, where you are optimized. Hormone Therapeutics will analyze the results and come up with a health plan to optimize health. Many doctors and nurses serve on the team to determine a client's plan. Your scientific map can be decoded through right tests and can provide individualized plans for wellness that no primary care physician can. Most primary care physicians get 4 hrs of nutrition credits while at school and 0 hours about monitoring the endocrine system. Hormone therapeutics can bridge that gap for the patient and primary care doctor. Then, the company can do periodic monitoring to ensure optimization of the wellness plan. These results can be shared with the primary care physician to help with local treatment. Hormone Therapeutics is also moving into the employee wellness field and doing employee testing and monitoring. They can all employees for a fraction of the cost of what other companies charge to provide this service to the company executives only.

Any primary care doctor who would like to offer Hormone Therapeutics in conjunction with the care they provide, or people wanting to implement employee wellness can email Check out the website

If you don't fall, you're not trying hard enough. You're going to fail, so you must be adaptive, have a mission, and have a great team. Hormone Therapeutics has a mission to add 20 healthy years to every life. The biggest difficulty they have know is figuring out how to reach potential clients because people typically look for local healthcare providers, not large companies offering telemedicine. Hunter is confident that he and his team will find a solution.

Personal Habits of Success
Hunter feels lucky to come from an amazing family with phenomenal parents and two amazing sisters who inspire him. He continually sets out goals, driven by how he can help people. He's learned that as the bar is set higher to make sure he's meeting his own expectations, not things others set for him. He's also learned that it's important to enjoy the moment, enjoy the accomplishments, and enjoy working with a team.

Three Absolute Truths
1.  Exploration is important; learning and experiencing is life. Hunter wants to flip over every rock on the planet; he wants to see, smell, and taste everything.
2.  Friends and family are the most important aspect of your life. Tell them so!
3.  Find your passion. Find a way to combine passions, skills, and interests. Make work not feel like work. Create the life you want to live by integrating passion.

An entrepreneur is someone who sees the world differently. They can see that something is missing and figure out how to fill that need.


Hunter Howard has founded three innovative HealthTech companies, following Fortune 100 Management experience, using leading technology and global business strategies for disruptive advantage. Howard also founded MediGain medical billing and led it to a successful Private Equity exit. He is an investor in and advisor for digital health startups. Hormone Therapeutics provides patients a 'Scientific map to personal health optimization' through in-home testing (blood, saliva, genetics, telomere, microbiome) and guidance through a national telemedicine platform.  Email him at

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Thursday, June 15, 2017

Hold Your Business Associates Feet To The Fire

Documented HIPAA compliance training is NOT an option for your Business Associates!

With the focus of the Office for Civil Rights (OCR) so squarely on the Business Associates of Covered Entities, it is more important than ever to hold your Business Associates feet to the fire when it comes to providing proof of their HIPAA training.

It is strongly recommended that Covered Entities require {45 CFR 164.502(e), 164.504(e), 164.532(d) and (e)} all of their Business Associates to provide them with documented proof of their HIPAA compliance training. This documentation could come in the form of individual employee training certificates or (if the Business Associate does not have training certifications) a signed addendum along with your Business Associate Agreement (BAA) attesting to the fact that the Business Associate's HIPAA training program was completed and will continue to be on an annual basis to maintain a standard for ongoing compliance training and awareness of evolving standards.

Far too often, I have talked with Covered Entities who's Business Associates verbally claimed that all of their employees were HIPAA trained, but could not provided documented proof. Simply saying, "Yah sure, we do HIPAA training..." is not enough proof for OCR. It is vital that Covered Entities are able to provide documentation of their Business Associates claim that they have completed their HIPAA training. If a Covered Entity is working with a Business Associate who either does not have documented proof of their HIPAA training program or refuses to supply the Covered Entity with such documentation, then that Covered Entity has two options:
  1. Recommend a BA HIPAA Compliance Training Program to their Business Associate;
  2. Begin exploring the option of no longer doing business with that particular Business Associate
Remember a BAA is a binding legal Contract and should be treated accordingly. Having Business Associates provide documented proof of a HIPAA training program will greatly assist in helping to limit additional liabilities for a Covered Entity and their patients.

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Monday, June 12, 2017

HCSI Interview with Dr. Robert Steves and Jennifer Steves of The Town Doctor Episode: 21

In this show, Lance King of Healthcare Compliance Solutions Inc ( interviewed Dr. Robert Steves and Jennifer Steves of The Town Doctor  ( about direct primary care.

Robert and Jennifer Steves have been married for almost 20 years and have 7 children. Besides homeschooling their children, they stay busy running a medical practice together.  Please see the Bio section at the end of the show notes for more information about their degrees and experience.

The Town Doctor
How it Began
Robert (Bob) got laid off a year ago from working as a doctor in a local hospital and advocated for better patient care. He saw that the doctor patient relationship was deteriorating in the United States. Patients get about 7 minutes of a primary care physician's time. It is not fair for the patient or the physician in that situation because it's hard to give high quality care with that short amount of time. Bob and Jennifer talked about the idea of direct primary care but were too nervous to actually do it until Bob was laid off. Jennifer immediately said “Let's do this” the day he was let go.
They built The Town Doctor together. They decided that it was the perfect opportunity to create a practice where they could care for patients the way they had always dreamed of. With direct primary care, insurance companies and 3rd party payers are cut out. Patients get 45 minute appointments. Bob used to see 35-45 patients and day; now he sees 6-8 patients in the same amount of time. Because they are released from insurance regulations/requirements, they are free to avoid pre-authorizations and can negotiate with labs and other service providers to pass on savings to patient, and can treat patients over the phone, text, or email. He gets to know his  patients, their families, and their jobs. Bob has learned about patient needs and situations that he never realized before in his former experience. He has been able to give higher quality care that focuses on well-being through the direct primary care model.

Covering Costs
The Steves are often asked about the practice's ability to cover costs since the patient volume is much lower than with a traditional PCP model. They tell people that they can definitely make money—they have 7 children to take care of! Overhead is cut by 80 percent in a direct primary care model because they don't work with insurance companies. Not only does this save time on paperwork, it also eliminates many hoops a doctor has to jump through to give care. Additionally, the have negotiated deals with services such as X-rays and lab work and pass the 90 percent savings on to their patients. For example, at his previous practice, a patient would have been charged $2200 for blood work that The Town Doctor charges $20. Bob says that his model is about more than just he money, though. He is willing to take a bit of a pay cut to enjoy a better quality of life, not just at work but also with his family. A lot of colleagues said it was professional suicide, but they all tell him that they would love to work his way. He is at peace with the way he does things because he knows it's right.

Biggest challenge
The biggest challenge the Steves have at The Town Doctor is educating patients on how direct primary care works. Bob is thankful to have a great team that help with the details. He had a  vision and knows it took many people working together to realize his dream of The Town Doctor. They work well with and complement each other. Bob says his wife has become an industry leader in direct primary care. Nurse Amy has been with him since he was a resident and she has been a huge help in the clinical side of things. Jennifer's mom works in the office, as well so it's been a family affair. Bob said that going against the grain of American medicine was difficult at first, but they trusted that God would show them the next step as they went. He remembered one of his professors in medical school said, “If you're taking care of your patients, you're going to be successful.” He has found that statement to be true. 

Advice for Doctors Looking to Make a Change to Direct Primary Care
The Steves want to remind doctors who are becoming disenchanted with the current model of medicine that you aren't stuck. He believes that doctors have ability to create and do something different. Doctors need to step out as a group and say, “Enough is enough.” Bob speaks to third-year medical students and tells them to think about the things that could be different in family practice. Bob and Jennifer will gladly take calls and give advice to doctors looking to get started in changing to a direct primary care model for their practices.  The Town Doctor office number is 615-547-6930. Their website is

Personal Habits of Success
Bob says that watching his father was greatly influential in his life. His dad was a blue-collar worker, plowing snow to provide for his family. They were a  poor family, but his father was committed and had an exceptional work ethic. Bob learned, “No matter what your position, give it your all.” People will see that drive and it will be rewarded.
Jennifer says that her determination has served her well over the years. They were 19 and 20 when they got married and they had kids early, while Bob was in medical school. People told them they were crazy, but they made things work. They chose to home-school their children, and were different in many cultural ways.  When told, “You can't do that!” Jennifer responded with, “Watch us!” That attitude helped her when starting the new practice. It was not easy and required many hours and lots of determination. Now she is able to see the rewards—freedom. The Town Doctor does what's best for patients instead of insurance companies. She and Bob have the freedom to enjoy time with family.

Bob says, “Keeping the patient first brings its own success.” He focuses on building things that surround the patient, like wellness programs, to promote the health and well-being of the patient. These ancillary services bring more money to the practice, but that's not his primary focus. He went into medicine for the relationships. He, doesn't want to sell this product or that product. He wants to grow the direct-primary-care-style of practice because it provides higher quality of care for patients and better quality of life for doctors. In fact, most of his patients have insurance but choose to see him because of the service they are given.
Jennifer says that being a practice entrepreneur who utilizes the direct-primary-care-model allows her and her husband to bring integrity to the forefront of their practice. She has the freedom to show a vendor the door who does not act in integrity. Her favorite thing about being an entrepreneur is that they get to create the vision they have for medicine in their very own family care practice.

Parting Advice
“When you feel something in your soul, don't ignore that. Its something that's been placed there for you to pay attention to. Write it down. Some people have dreams, some people will beat their dreams into submission. Chase down your dreams.”-Bob
“It's okay to be different...Amazing things can happen.”-Jennifer

Bio for Dr. Robert Steves and Jennifer Steves of The Town Doctor
Dr. Robert (Bob) Steves
Dr. Robert Steves obtained a Bachelor of Science degree, Cum Laude, in multiple sciences from Lemoyne College in 2001. He graduated with a Medical Degree, Cum Laude, from St. George’s University in Bayshore, N.Y. in 2006, and completed the Family Practice Residency Program at St. Joseph’s Hospital Health Center in 2009. He is highly skilled, professional and compassionate. He works continuously to update his medical knowledge. His commitment to preventative care extends far beyond the walls of his practice, educating people on the benefits of wellness and prevention at every opportunity. Dr. Steves’ experience studying medicine in a 3rd World country, the urban Detroit area, the suburbs of Syracuse, and most recently the growing Middle Tennessee area has provided him a depth of knowledge and broadened his experience in acute and preventative care. Over nearly 20 years, he has participated directly in all areas of family practice medicine, including administrative, insurance, and in the laboratory, which has enabled him to have a well-rounded approach to medical and disease management. Extremely articulate, his natural teaching ability, and experience commands an audience when educating and presenting to patients, as well as the health care team.

Jennifer Steves
Jennifer Steves is both a Registered Nurse and a health and wellness professional with a broad level of experience both clinically & administratively in the health care industry. She works to educate healthcare consumers, and connects individuals and employers with The Town Doctor™, Direct Primary Care; an improved and cost-effective healthcare solution. A registered nurse & visionary leader she utilizes her experience from her years in the hospital & clinic turning strategy into operational success through planning and directing operational policies and objectives. Responsible for establishing and overseeing standards, executing overall vision, implementation of marketing strategy, developing & maintaining relationships with key executives, and working with staff to ensure that processes, training, and quality of services reflect the high-quality standards and performance expected. She reviews data-based reports and overviews that can be acted upon to both improve and ensure the business’ top efficiency and performance. Together, their knowledge has positioned them as an industry leader in Direct Primary Care where they specialize in clinical & consultative services for employers, health care organizations, brokers, insurance companies, and health care providers that positively is impacting families, businesses - and their employees by providing BETTER ACCESS, BETTER CARE, & BETTER HEALTH.

Thank You!
Thank you for watching and listening to our interviews. Please follow us on Facebook @hcsi, listen to the Doctor Entrepreneur podcast, and watch more videos/interviews on YouTube. For Healthcare Compliance help, visit the Healthcare Compliance Solutions, Inc website at

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Thursday, June 8, 2017

Informed Consent, Consent to Treat and Informed Refusal

A Compilation of Resources Discussing Informed Consent, Consent to Treat and Informed Refusal

As providers redefine processes to ensure more patient-centered care, you will want to reassess your informed consent approach to ensure that it abides by all regulations and protects the provider, patient and practice. Informed consent is a routine aspect of healthcare yet it is one of the most misunderstood concepts even among experienced physicians. This misunderstanding stems from a failure to understand all of the elements that comprise informed consent and recognize the ramifications of patient allegations that he or she did not understand the benefits versus drawbacks of a provider’s treatment recommendation.

A history of informed consent

Hippocrates, who gave us the first set of western writings on conduct for medical professionals, suggested patients are best served when physicians conceal most information. It was not until the 18th century writings of physician Benjamin Rush that we began to see recommendations that physicians share information with their patients. The publication of Medical Ethics in 1803 by Thomas Percival advocated the notion that while patients have a right to the truth, a physician might lie or withhold information if it results in better treatment. Informed consent gained more ground as a result of the atrocities committed by the Nazis who routinely experimented on human subjects.

The American Medical Association via Opinion 8.08, Informed Consent, says, “The physician has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice.” Adopted in 1981 and updated in 2006, the opinion reads, “Physicians should sensitively and respectfully disclose all relevant medical information to patients.

The main purpose of the informed consent process is to protect the patient. A capable adult cannot be forced to have any type of medical treatment. In general, anything other than a life-threatening emergency in which the patient is unconscious requires consent before treatment. Even in that situation, consent may be required if the patient is known to have an advance directive.

The Advance Healthcare Directive
An advance health care directive or advance directive is a kind of legal document that tells the doctor your wishes about your health care.
Advance directives can be general, with very few directions about your care. The directive may just name a substitute person (proxy) to make these decisions for you if you are unable to do so. Or it may include instructions for the chosen proxy.
Advance directives can also be very detailed and clearly outline the different types of life-sustaining treatments you would accept or refuse in certain situations. Some types of advance directives are limited to certain situations, like the living will, organ or tissue donation, or your wishes not to be revived (resuscitated) if your heart or breathing stops.
Who besides the patient is allowed to consent?
For children or others who are unable to make the decision for themselves, the parent or legal guardian is legally responsible for getting the information, making the decision, and signing the consent form. But that doesn’t mean that the child or patient who is not considered mentally competent is always left out of the process. Some facilities require the assent of older children before they go into a research study, even after the parents have agreed on the child’s behalf. Assent means that, even though the parents sign the form, the child must also be OK with the plan before the facility will do the treatment.
Along the same lines, people who are unable to manage their daily affairs because of impaired thinking or emotional problems might still be able to understand the medical situation and make their wishes known. They should be given information in a way they can understand, and asked what they want to do.
In the event that you become unable to take in information and make your wishes known, another person may be asked to take part in the process of informed consent. There are several ways that person can be chosen.
  • Durable power of attorney for health care -- The only way you can choose the person to make these decisions for you is to set up a durable power of attorney for health care (also called a health care power of attorney). In this case, if you are unable to speak for yourself, the person you chose becomes legally responsible for making medical decisions on your behalf. This person is sometimes called your proxy, agent, or surrogate.
  • Court-appointed proxy -- Another option is a court-appointed surrogate or proxy. This is someone a judge chooses to make medical decisions for you. If you become unable to make decisions for yourself, someone else – such as the doctor, facility, a friend, or a family member – may ask (petition) the court to appoint someone to do it for you. The process varies from state to state.
  • State family agency acts -- Many states have passed family agency acts that choose which family members (in a listed order of priority) may act on behalf of a person who cannot speak for her- or himself. This option may be used if you don’t have an advance directive or court-appointed proxy. Depending on your family situation and which state you are in, that person may be your legal guardian, spouse, parent, child, sibling, or other relative.
A consent form is not needed for simple diagnostic tests and situations in which your actions imply consent. For example, if you see your doctor and allow a blood sample to be taken for lab tests, your consent is assumed because you went to the doctor seeking care and allowed blood to be drawn. At any point, you could change your mind and decide to refuse testing, leave the doctor’s office, or seek care elsewhere. This is different from a treatment that puts you in a vulnerable position or can possibly cause serious harm. You need more information about more risky treatments so that you can weigh your options and consider your risks before making a decision.

Even when there are no other accepted medical treatment options, it’s still your right as a competent adult to refuse a treatment that you don’t want or refuse to be in a study that you didn’t choose. But once you sign the consent form, it’s taken to be a formal, legal agreement that you are OK with the plan or procedure that’s listed on the form unless you revoke (take back) your consent before treatment is given. The doctor or facility will usually give you a copy of the consent form, but they keep the original as a legal record that you agreed to the treatment.
For example, a physician makes a recommendation to a patient for surgery and leaves the exam room. A nurse enters, puts a form in front of the patient and asks if there are any questions. The patient, still absorbing the news that he needs surgery, has no questions and signs the form. The surgery proceeds but does not go as planned. Soon thereafter, the physician is served with a claim for malpractice and medical battery citing, among other issues, a lack of informed consent.

Who wins? The answer is that no one wins.

Whether there is an adverse event that permanently affects the patient’s health or a patient believes he or she was not given all the necessary information, the patient walks away feeling shortchanged and the trust established with the physician is lost. Worst-case scenario, the patient’s health is adversely affected by a decision that would not have been made with better information, and the physician faces years of litigation that will affect the practice and his or her personal well-being.

Informed consent has been referred to in terms of medical ethics and treatment variation, but the task of obtaining informed consent is a practical issue that can be included in process review and regular staff meetings to ensure that providers are protected from malpractice allegations.

Informed consent

Far too often, physicians provide a treatment recommendation and the implications for not following it stop there. And while informed consent is a routine expectation, especially for high-risk procedures and drugs, it generally is not a legal requirement though informed consent requirements vary by state.

These requirements might be enacted by law or could be included in the policy documents of a state governing medical board. They might also be found in case law for malpractice claims. Because of failure to fully appreciate what constitutes effective informed consent and the inconsistency of requirements across the country, it is often not given its due diligence and can become a pretense for doing the right thing in name only with no meaning. Even when a physician believes they have imparted enough information for a patient to make an informed decision, a patient and a jury might disagree.

Informed consent can take two forms: implied or express.

Implied consent is generally associated with lower risk treatments and procedures, such as immunizations. While disclosure must be made regarding benefits and risks of an injection, generally via a Vaccine Information Sheet (VIS), we generally do not obtain signatures before an immunization unless it carries significant side effects or unknown risks. Instead, we rely on the patient rolling up their sleeve and presenting an arm as evidence of consent. In comparison, express consent is more formal. It is evidenced by a patient or guardian/power of attorney’s signature on a form.

While often referred to in varying terms, the elements that make up an informed consent discussion can be broken down into four categories, which should be included on your informed consent form:

Risks: What is the danger from a recommended treatment? Not every potential adverse outcome has to be mentioned but physicians know which outcomes are most likely to affect patients and those should be addressed. For example, a hand surgeon would probably have a more in-depth conversation with a world-renowned concert pianist than the average patient because an adverse outcome would alter the pianist’s career and life in different ways. Groups might want to consider what procedures or routine activities require express versus implied consent and establish a policy to avoid staff and provider confusion. When in doubt, go for the express consent to protect yourself. In theory, if a patient is properly educated, the execution of a signature on paperwork reflecting this should add very little time on the front end but could save years of wasted time in litigation on the back end.

Benefits: What can be gained from the treatment? Or what can a patient realistically expect to achieve from adhering to the prescribed treatment? For example, will a patient’s pain be minimized or disappear? Will life expectancy increase? Are there limitations? A discussion about the likelihood of potential benefits is prudent, and you should also talk about factors that would prevent this patient from falling within the general expectations.

Alternatives: Are there other treatment choices that should be considered? For example, should a patient consider a nonsurgical approach, such as glasses or contacts in lieu of Lasik surgery? Keep in mind that alternatives include pursuing no treatment, which should be included as an option no matter how wrong you might think it is. The issue of cost for various options might be worth mentioning if there is a significant difference, especially for patients with no insurance. There will be varying opinions among physicians about how to handle alternatives, which they might not advise but it is important for physicians in groups to operate uniformly. Conflicts should be resolved within the governance structure of the organization. Physicians should be encouraged to consider their ethical obligations and reach consensus. Physicians can certainly offer options without endorsing them and be as candid as possible with patients.

Consequences: What are the potential implications of a patient’s decision, whether it is to follow a recommended treatment, pursue an alternative or do nothing? This is when most physicians typically are asked, “What would you do?” There is no harm in answering this question, but remind a patient that he or she has to make the decision based on his or her unique situation.

Informed refusal

While some states require signed consent for certain procedures, such as sterilization, the vast majority have few or no rules. Even when not required, an informed consent form is invaluable in defending a malpractice claim. However, an informed refusal form is equally valuable.

An informed refusal form is really just a twist on an informed consent form and while it is not commonly used, it is worth its weight in gold from a defense perspective with a noncompliant patient. The real difference is that instead of acknowledging and accepting the risks of treatment with an informed consent form, a patient acknowledges the risks of not following a physician’s recommendations. The form acknowledges that a patient is choosing an alternative treatment or no treatment at all and any accompanying consequences. These are particularly important with noncompliant patients to demonstrate that they have made educated decisions to not follow provider advice and knowingly accept the consequences.

As frustrating as it can be, competent adults get to make their own healthcare decisions. That word “competent” is key here. Informed consent discussions should occur while a patient is coherent and able to have the discussion. Ideally, the conversation should occur when the patient is best able to understand the information, which might require a follow-up appointment if the patient has just received difficult news or needs a family member present.

Do not initiate this type of discussion after drugs have been administered or when a patient is distraught over a serious diagnosis. That could result in a signed form being declared void for lack of competency at that moment. (It has happened.) Obtaining a signed form at this point opens a physician up to a “he said/she said” argument that can easily be avoided. And while most physicians understand this, it is important to ensure that the team members who assist a physician also understand these guidelines so they do not pressure a patient for a signature after medications have been administered.

If a situation goes to court, a patient might allege that he or she did not understand the conversation or did not have the opportunity to ask questions. While a patient can still make this assertion, a signed form goes a long way with a jury to show that processes were followed. And a jury ultimately decides the issue in a trial situation. If you choose to not use a form and obtain a signature, it is still wise to document the conversation in the medical record. A note made at the time of the discussion bolsters a physician’s account of what transpired. Lawsuits can take years to reach the deposition or trial phase, and if a physician acts as a witness in his or her own defense, citing a written note is more reliable than relying on his or her memory.

Any number of resources can be used in the informed consent process, such as printed patient education materials, websites and videos. Physicians might also use experienced staff to talk with patients and address questions. That team would include a nonphysician provider, nurse, medical assistant or anyone else who a physician believes has the skill and knowledge to discuss treatment options. However, the physician is ultimately responsible for ensuring that the process was properly conducted and that he or she was available to answer any questions. Failure to do so can result in dissatisfied patients, which carries its own ramifications, and it can prompt needless litigation.

See: Weinmeyer R. “Lack of standardized informed consentpractices and medical malpractice.” AMA Journal of Ethics. February 2014;16(2):120-123.

Requirements for Informed Consent

Informed consent is an ethical concept—that all patients should understand and agree to the potential consequences of their care—that has become codified in the law and in daily practice at every medical institution. One of the earliest legal precedents in this area was established in 1914 when a physician removed a tumor from the abdomen of a patient who had consented to only a diagnostic procedure (Schloendorff vs. Society of New YorkHospital). The judge in this case ruled that the physician was liable for battery because he violated an “individual’s fundamental right to decide what is being done with his or her body.” The first case actually defining the elements of informed consent occurred in the late 1950's and involved a question of potential negligence and whether a patient was given sufficient information to make a decision.

The case law and rules pertaining to informed consent have changed over the years and all 50 states now have legislation that requires some level of informed consent. Although the details of these laws vary from state to state, the bottom line is that failure to obtain informed consent renders any U.S. physician liable for negligence or battery and constitutes medical malpractice.

Exceptions are made for emergencies or legally adjudicated mental incompetency or physical incapacity. Several of the common elements required for full disclosure have been summarized by the American Medical Association (Table 1 - below) and other groups representing specialists or quality assurance organizations. For example, federal regulations spell out the minimum requirements for a properly executed informed consent form (Table 2 - below) and state that this form must be in the patient’s chart before surgery. [CFR Title 42] These regulations also stipulate that the information must be given in a language or means of communication that the patient understands. The U.S. government requires interpretation and translation services for individuals with limited English proficiency at institutions that receive federal funding; these regulations also state that informed consent forms must be translated into languages spoken by 5% or 1,000 of a provider’s patients—whichever is less. [Executive Order13166]

The Basic Features of Everyday Informed Consent - [Table 1]
The physician (not a delegated representative) should disclose and discuss:
  • The diagnosis, if known
  • The nature and purpose of a proposed treatment or procedure
  • The risks and benefits of proposed treatment or procedures
  • Alternatives (regardless of costs or extent covered by insurance)
  • The risks and benefits of alternatives
  • The risks and benefits of not receiving treatments or undergoing procedures
Source: AMA 1998

What’s Needed on the Informed Consent Form - [Table 2]
  • Name and signature of the patient, or if appropriate, legal representative
  • Name of the hospital
  • Name of procedure(s)
  • Name of all practitioners performing the procedure and individual significant tasks if more than one practitioner
  • Risks
  • Benefits
  • Alternative procedures and treatments and their risks
  • Date and time consent is obtained
  • Statement that procedure was explained to patient or guardian
  • Signature of person witnessing the consent
  • Name and signature of person who explained the procedure to the patient or guardian
Source: Federal Code (Title 42 C.F.R. § 482.51 (b) (2)) Interpretive Guideline A-0392

Which procedures require informed consent? Unfortunately there is no continually updated national list describing exactly when informed consent is required. Again, it varies from state to state and is also influenced by clinician or hospital interpretation of recommendations from professional and specialty groups.

For example:
  • Pennsylvania state law specifically requires that consent be obtained for blood transfusions, chemotherapy, and methadone use as part of a narcotics treatment program. [PA Law Code]
  • Many states have developed specific laws governing breast cancer diagnosis and treatment. [ACS 2007]
  • The American College of Obstetrics and Gynecology has developed detailed guidelines for informed consent issues related to sterilization and carrier testing for cystic fibrosis. [ACOG 2004]
  • Increased levels of institutional quality (e.g., compliance with accreditation standards)
  • Potential time and money savings (or offsets) related to reduced litigation
Thus, based on guidance from staff and counsel, each institution generally develops its own list of surgeries, procedures, or situations where full informed consent is needed. In fact, the Joint Commission (formerly known as the Joint Commission on Accreditation of Healthcare Organizations or JCAHO) has set a standard that hospitals must establish and follow policies that describe which procedures or care, treatment, or services require informed consent. [Joint Commission 2005] One of the first steps recommended is to clarify your institution's policies about when informed consent is required.

Another area subject to local interpretation is exactly how much to disclose. How many potential risks must be described, for example, and how many alternatives must be mentioned? While many states rely on a standard of what a “reasonable physician” would provide or what a “reasonable patient” would need, this still leaves room for interpretation. Most laws describe the need to cover all “material” (i.e., significant) risks. But common sense suggests that not every potential risk can be described in detail and that only the most prevalent and/or serious risks and side effects would be covered. The number and type of complications also may vary widely depending on the severity of the patient’s underlying conditions or comorbidities (e.g., pneumothorax following central vein catheterization may not be life-threatening in a patient admitted for a soft-tissue abscess but could be extremely risky in a patient receiving mechanical ventilation for severe acute respiratory distress syndrome). How can a single form cover both situations? Further complicating the issue, of course, is the fact that there are limitations and variations in the capacity of individual patients to comprehend many of these details—and therefore the information needs to be tailored for each individual.

It is precisely these gray areas in the requirements for informed consent - When is it needed? How much is needed? And how can I make sure the patient understands? - that have opened the door for many of the documented failures of informed consent in everyday practice. (See below: “Informed Consent in Practice”).

One common defensive response to the uncertainties about how much to disclose, for example, is use of “blanket” informed consent forms that contain only boiler-plate generalities that “all potential risks and side effects and alternatives have been explained and understood by the patient.” If such a generic consent form is accompanied by genuine documented education involving appropriate explanation and printed material, this may work. (Attorneys also usually advise clinicians to document the details of this interchange in the patient’s record.)

But on its own, an overly generic consent form without any significant accompanying education, interchange and documentation - that is, a quick request for a signature while the patient is on the gurney - is not adequate. On the other hand, an exhaustive list of all the potential risks may be difficult for patients to understand. (Attorneys reviewing such a list would also likely point out that any omission from such a long and seemingly comprehensive list might be a red flag, and that such a form would therefore need to state that the list is not inclusive. [AMA 1998])

Informed Consent in Practice
  • How often does informed consent work as intended?
  • How do your practices match up to the national norms for informed consent?
  • How does one even begin to measure the “success” of informed consent?
These are complex questions that have been tackled by clinicians and researchers from different settings and perspectives. Many studies have focused on one therapeutic area of interest. Others have analyzed the consent process only in the research setting. And some have evaluated the process in targeted patient groups such as those with low literacy.
Reviewing the results from such studies provides a sense of the problems that must still be overcome in planning for and delivering informed consent in everyday clinical practice. While much of this data comes out of the clinical research setting, many of the broader “lessons learned” in these studies are highly applicable to the setting of everyday informed consent.

Best Practices

Developing an Informed Consent Form

Download this Style Guide template for improving you Informed Consent Form(s).

In summary and based on all of this information, two points stand out:
  1. Patients have a fundamental right and need to receive information, both orally and written, about their care in a manner they can fully comprehend and that will lead to truly shared decision-making, and 
  2. current practices of informed consent are often inadequate and are especially hampered by growing rates of health illiteracy in the U.S. 
A number of studies indicate that improving consent forms and the overall consent process can lead to better patient comprehension and recall. Although the research on improved consent forms has been mixed, some studies have found that when consent forms are improved, patients are more likely to read and understand them before signing. Using a consistent informed consent template as a starting point for the creation of forms for various procedures also appears to improve consistency and quality in the forms. Providing clear and simple information about procedures may also lower patient anxiety levels and increase understanding and recall in a way that produces a more deliberative decision-making process.

However, a clearly written consent form does not guarantee that patients will read and understand them. A properly constructed and clearly formatted consent form is a necessary but not sufficient condition for ensuring that patients read, understand, and remember the information presented. Thus, a variety of other methods are needed to increase patient involvement in the consent process and improve patient comprehension of the information presented. For example, several recent studies show that repeating information to patients in various formats and modes and at different times can strengthen comprehension and recall.

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Monday, June 5, 2017

HCSI Interview with Todd Stabelfeldt CEO of C4 Database Management Consulting

This show features an interview with Todd Stabelfeldt, the CEO of C4 Database Management Consulting ( by Lance King of Healthcare Compliance Solutions, Inc (

Todd Stabelfeldt
Todd grew up in a German, military household and love was based on performance. He was shot at age 8 in the spinal cord and hasnt' been able to feel or move from neck down since. At age 9 his mom said he would have to move out when he was 20 years old so he knew he had to be successful in school and plan on getting a job. When he was 6 he wanted to be a Navy seal, then he was crippled and he decided to be a psychiatrist. After graduating high school early and taking some college classes, he decided that he needed to forego medical school and get to work. He got a job at a medical software development company, and later went on to start C4 Database Management Consulting. He is married with 2 kids, a dog, and a cat he doesn't want. He has a fantastic life. He can see how tough-love made him strong and his step-father's unconditional love made him the man he is today. He teaches his kids that you don't get a trophy just for showing up.  Todd also likes to teach people about how technology advancements have changed his life. He especially likes to show Apple store employees how Switch controls can help disabled customers. To aid in educating people about the enabling technologies available, Todd started the Todd Stabelfeldt Foundation. You can learn more about it at

Emily Warren
Emily has known Todd for 20 years. She worked in a pathology lab in Nashville, which used the software that Todd's previous employer developed, and so they got to know each other professionally.  When Todd started his own firm she wanted to join to get back to database management where her core strengths were. She loves being able to work in Nashville, even though Todd is in the Seattle area. She's thankful for the technology that makes it possible for them to work together over such a long distance.

C4 Database Management
When Todd left his previous employer, he thought databases were just taken care of. He realized that most people don't know what happens with data in healthcare, or how to restore data when something goes wrong. There is a huge need for database experts and that need will continue to grow. C4 is like an insurance policy that makes sure the data is secure and recoverable in cases of hacking, ransomware, system crashes, etc.
When first meeting with a client, C4 will first do a health check of the database to see where the weaknesses lie and if the data is backing-up correctly. Then the team will meet with the client and discuss a plan for monitoring the database. C4 works with a provider's IT department, as a value-add, not a replacement for that department. C4's clients consist mostly of labs and hospitals. The company is not reactive; it is very proactive in everything it does. C4 started with patient database management, but  has grown organically, driven by customer requests. Todd enjoys the chance to serve millions of people who don't even know him. He says that doors open as you stay humble. Anyone interested in using C4 Database Management Consulting's services should contact them via the information found on the website,

Habits of success
Emily's habit of success is staying focused. She remembers that patients are more than piece of paper. She says if you lose focus, you just float around.
Todd's habit of success is knowing who he is. He's not a crippled kid, whining about what happened to him. He's grown, real, legit, and comfortable with who he is. He says, “Get up every day and do you; don't stray from the path.” Also, “When your wife tells you to man up, get up and do it.”

3 Absolute Truths
Todd's absolute truths are short and simple: 1-Jesus, 2-Karen Stablefeldt, 3-Emily Warren
Emily says her absolute truths are as follows: 1-Love yourself. Don't let anyone bring you down. 2-Family as a whole is important; it takes a village to run her life 3-She wants to get up every day and love what she does; she loves being able to take care of others.

Entrepreneurship: Changed Over Time
At the beginning, Todd said he accepted anything and everything as a job. He didn't know who he was. A client told him he would be a good employee but sucked at being consultant. She told him to “know who you are and you'll attract the right clients.” He has found that statement to be true. Emily says not to get caught up with what someone else is doing and play to your strengths.

Emily Warren
C4 Database Management provides clients with database management and computer systems consulting services. As Director of Customer Service and Operations,  Emily manages a wide range of client needs including assessing and implementing LIS system enhancements: upgrades, interfaces, custom reports and more. In the process,  she leverages her knowledge of multiple LIS systems, active directories, and related hardware and software to deliver quality service to C4’s customers. In this position, she also oversees internal C4 operations and sales management tasks. She assesses customer needs and collaborates with C4 management on developing solutions to address the continually changing needs of the C4 client base. Additionally, she supervises the internal production management system to plan project implementations and balance workloads for the team.

Todd Stabelfeldt
As CEO, lead software engineer and DBA, Todd oversees IT projects typically based on SQL databases in healthcare laboratory, government agency, and other industries. He initiates engagements by consulting with customers and then providing roadmaps to implementation and ongoing maintenance. His projects in the anatomical and clinical pathology IT space extend into certain specialty areas: Corepoint software implementations for interface development, lab results data management, and billings systems. Todd’s consultations involve the management tools used in these environments such as Kronos, Meditech, PowerPath, Psyche, Orchard, and Cortex as well as general IT management tools like Autotask (AEM) & Kaseya.

Thank you!
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C4 Database Management Consulting Interview

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