Michael Sacopulos, JD. Partner with Sacopulos, Johnson & Sacopulos

With the current economic uncertainty, dentists are questioning their commercial office space needs.

According to Dr. Jeffrey Spiegel, who has been a practicing facial plastic surgeon for 13 years at the Boston University of Medicine, leasing has advantages including increased flexibility, tax benefits and reduced responsibilities.

Dr. Spiegel opened a new office in a Boston suburb and has been in his new space for roughly a year and a half. After much searching he decided to lease the space.

“I chose to lease because the places I wanted to be didn’t have anything appropriate for sale,” Spiegel said.

Dr. Spiegel said he was cautious not to ink the contract too quickly. He carefully considered the layout of the office, city codes and signage laws before choosing his new location.

“One thing you should know are the codes,” Spiegel said. “There are specific rules regarding the number of bathrooms, size of rooms, egress, and ingress that you may look at a space and have an idea of how you would build it out. But the help of someone who knows the codes, preferably an experienced person in medical space, is going to be very helpful.”

That is where experts like Shara Lerman with the firm 

 come into play. Lerman recommends not signing a lease without a lawyer or real estate professional examining the document to make sure all the terms and provisions are in proper order.

Lerman says it is pretty common for a provider to want to handle the lease arrangements on his or her own to save money.

“The hour it takes us to look at a draft is a lot cheaper than us having to come back to renegotiate,” Lerman said. “Usually there is some kind of problem or situation where there has been a disagreement and now they are working it out. It is going to take a lot more time, energy and expense to fix something after the fact.”

Lerman says huge problems arise when providers are leasing space in a hospital. She says to them it is a giant person versus a little person and they have problems getting things in writing.

“We have to point out to them that it is in both parties’ best interest to have everything in writing because liability can go both ways,” Lerman said.

Dentists must guarantee that they do not enter into an arrangement that violates Stark Law or Anti-Kickback Statue. The Stark Law prohibits a dentist from making a referral for certain designated health services to an entity with which they have a financial relationship. A lease agreement qualifies as a financial relationship. The Anti-Kickback Statue prohibits payment to induce or reward referrals of items or services that are reimbursable by a federal health care program. To avoid liability under these regulations, dentists must make sure the lease arrangements meet Stark Law and the Anti-Kickback Statue.

“We will wind up having to step in and go to the legal counsel of the hospital because on the other side you are dealing with an administrative person who says to you, ‘this is just our form, you have to sign,'” Lerman said.

 The rent payment must be set in advance and in writing. Revenue and business generated cannot dictate the cost. Will you be paying a triple net lease? This means you will be paying for all of the real estate taxes, insurance and maintenance in addition to any normal fees like rent, premise and utilities.

 (MOU). It is the old adage, what I said is not what you heard.

“I had a client who put tons and tons of stuff in the building and was not able to take it with him when he left,” Lerman said. “He was 

 he could, as long as he restored the space back to its original condition. Then, a paragraph in the lease stated that anything installed must remain.”

He connected his anesthesia machine into the vent going outside. Therefore, it became a permanent fixture, although with a couple screws he could have disconnected it.

“It was a $25,000 piece of equipment and the landlord made him leave it and he had no choice,” Jay Shorr, Founder and Managing Partner of the Best Medical Business Solutions, said.  

What are the rules of the building or association

? Are multiple, similar specialties prohibited? Shorr recommends that if you are the first of a specialty in a huge complex to demand exclusivity.

“A guy signed a lease only to find out that another dentist has a restriction on specialty,” Shorr said. “After the guy spent all kinds of money to open up a new practice, the other dentist pulled out his trump card two days before the grand opening of the new tenant. They had to go to court, do an injunctive order to stop the new tenant from opening. Then what happened is, they ended up suing the attorney for the landlord under the errors and emissions policy because it was the landlord’s obligation to disclose any type of situation like that and they failed to do that,” Shorr said.

You want good office space not good litigation, so check for exclusivity provisions.

What services does your space come with, for example snow removal? Whose liability is the parking lot? View their insurance policy before you negotiate the lease because you might not be covered if someone slips or falls. Is there enough insurance even if you are covered?

Before you sign on the dotted line heed the aforementioned advice. Most importantly, understand the level of authority of the person you are dealing with. The person you may be talking with may not have signature power. Make sure you have everything in writing and don’t be afraid to walk away from a deal.

Michael J. Sacopulos is the CEO of Medical Risk Institute (MRI) and serves as General Counsel for Medical Justice Services. Additionally, Mr. Sacopulos is the Legal Analyst for several national publications, including Dental Products Report. He may be reached at 

Articles

With the current economic uncertainty, dentists are questioning their commercial office space needs. According to Dr. Jeffrey Spiegel, who has been a practicing facial plastic surgeon for 13 years at the Boston University of Medicine, leasing has advantages including increased flexibility, tax benefits and reduced responsibilities. Dr. Spiegel opened a new office in a Boston suburb and has been in his new space for roughly a year and a half. After much searching he decided to lease the space.

How to lease office space without getting cheated

Your hands are your livelihood. In a flash, a career that took decades to achieve can come to an end. Meanwhile, the monthly bills keep rolling in and financial obligations mount as you’re out of work. This is an unpleasant but important topic for all dentists.

, based out of Cincinnati, Ohio, has roughly 800 dentists and physicians with disability insurance policies. At any given time they have 20 to 30 physicians making a claim. Generally speaking, there are two types of disability claims: short term and long term. Short term disability is used for when a physician will be out of work for a short period of time, for example, six months. The longer term disability is used when you cannot return to work in your current position. 

“I have a dentist right now who is in the midst of filing a claim. It will more than likely be a long term claim. He has carpel tunnel release and numbness all through his arm and into his fingers. I am not the doctor, but talking with him, there is probably a 90% chance he is not coming back to practice,” said OJM Group Managing Partner Jason O’Dell.

Are you prepared for life after dentistry?

Filing a disability claim can be a grueling process. Be prepared when the insurance company requests a lot of information; for example, when the incident occurred and all medical records from the attending physician. The insurance company will also want financial documentation including, past tax returns and updated financial records for the current year.

“It is a long, cumbersome process to get a disability policy to start to pay, said O’Dell. “There is a waiting period before your benefit would kick in. As soon as you think there is a chance of going out on a claim, there is no sense in waiting before you file a claim.”

If you purchase a disability policy, you still may not be fully covered. If you scuba dive on occasion that may not be a big deal. If you scuba dive in caves at night, 100 times a year, insurance companies are likely to exclude you or decline you all together. Other exclusions may include: active war, airline pilot and frequent indulgence in risky hobbies.

“I had a maxillofacial surgeon loose four fingers in a wood working activity; therefore, he couldn’t perform surgery anymore,” said O’Dell. “Make sure the policy has very specific definitions to protect you and your own occupation.”

When you sit down with a disability insurance carrier, examine their definition of disability. There are variables.

“You want it to say ‘the inability to perform the substantial material duties of your occupation’ period, end of story, nothing else,” O’Dell said.

Then you have residual definitions. Will your insurance carrier pay you in the event that you can work part time? Is there a cost of living adjustment? The value of a dollar changes over time. You want to make sure that monthly benefit increases with the consumer price index which is the cost of living adjustment

Be cautious of policies that state that even if you are not capable to continue doing your current occupation, you could work in another field. This type of insurance policy will offset payment to you by the new income you are receiving from the new occupation. Typically, you don’t want this kind of definition because if you can’t do your job, you want to be paid no matter what job you’re going to do. A policy specific to your occupation can increase the cost. Look at the monthly benefits the policy will provide you based on your income.

“The higher your income goes, the less percentage of it you can get insured,” O’Dell said.

The insurance company mentality is that the more income you’re making the more you should be saving. For those oral and maxillofacial surgeons with incomes in the six and seven figure range, they have the ability to get their income insured through companies like 

“The philosophy that we use at our firm is to insure what you have in terms of expenditures on a monthly basis, not what you earn,” explained O’Dell. “What is your budget on monthly basis, not what you earn. Let’s insure your budget.”

Filing a disability claim can be taxing. The self-proclaimed 

 of Scottsdale, Ariz., says one of her favorite things is learning how to play chess with the IRS’ rules to get that maximum deduction. Wekherlein says if a practice takes the disability policy as a deduction at the business level, meaning they are paying for all of it, and the employee/dentist is not paying for any of it, then the company can deduct the premium as an employee benefit. It is not taxable income to the employee. However any benefits from employer paid disability is taxable to the employee to the extent of the medical expenses.

“Place the onus on each individual person, this is one of the best ways to try and deduct the premiums but not necessarily pay tax on the income when you use it,” said Wekherlien.

Wekherlien says you are allowed to create a plan to really describe the disability insurance that you are going to be giving your employees as a company. In the plan, you are allowed to state each year if the individual is allowed to elect whether or not they are going to be paying these premiums pretax or post tax. You are allowed to choose in each year whether or not you are going to deduct those benefits or not. If in a year an employee becomes disabled he or she has elected to pay the coverage with his or her own funds meaning post-tax, then any benefits of that are tax free.

“If you have a dentist that is at a 40% rate and their insurance premiums for the year are 10,000 dollars,” said Wekherlien. “That is a 4,000 dollar tax shelter for them. Because you are allowed to elect annually which way you want to go, what you really want to do is hold your annual meeting on December 31

.  That way you will know in that year if you have become disabled or not.”

Do you find all of this complex? You should. It is. Here is the bottom line: You need to decide if you need disability coverage. Be careful of the terms, conditions and definitions in the policy because they vary. There are major tax considerations when buying disability coverage. Get quality, professional assistance. Disability policies come with a lot of moving parts. It is worth your time and effort to get the right policy in place for your protection.

How to outsmart your disability insurance policy

 should use to set clear financial arrangements and expectations for their 

Dr. Joseph Banker of Creative Dental Care in New Jersey has learned from his years of practicing dentistry all about patients who cannot pay. His experience has taught him that a dentist must spend the appropriate amount of time with patient, to educate them on their treatment options. 

Factors such as time frame, cost, and comfort must be considered. Once the desired treatment is selected, clear 

 arrangements are crucial prior to the inception of treatment.

“I encourage my patients to participate in the formation of their treatment plan. Some have the means to pay for extensive treatment in full while others prefer to spread their treatment over a longer period of time. Regardless of their financial situation, I am successful in helping my patients achieve optimal oral health. We make a plan, and we work our way through it at a pace that is comfortable for them,” Dr. Banker said.

Not every dental office may run as smoothly as Creative Dental Care. For those who find themselves sailing the rough seas can learn a lot from Patty Ricard. For more than 20-years she has been on the front line as an 

 for dentists. Her experience has led her to consult with dentists and their teams about proper practice management.

Patty says a dental treatment goes beyond written forms and starts at the Dentist’s office front desk. For Ricard, securing the right front office staff is key. A good question to ask a potential hire is ‘Are you comfortable asking for money?’

“Some people just don’t have it in their nature. It is a personality type and some people can do it and some people can’t,” Richard said.

What to include in a financial arrangement form

Solid collections take more than just the right staff. Practices should use the proper forms and documentation to set patient expectations. These forms also can create legal rights and options down the road.

Patty has designed a financial arrangement form that is meant to be reviewed with all patients line by line. Each form states the following:

			Estimated insurance payments (if any) - (key word that must be on form is "estimated")

			Estimated out of pocket costs after insurance (if any) -(key word that must be on form is "estimated")

			How much money is due upon scheduling or when treatment has begun (there are reasons for both options) and what dollars (if any) will be forfeited upon failing to appear for the scheduled appointment or last minute cancellation.

			A statement indicating that regardless of insurance estimates provided, the patient is ultimately responsible for the entire cost of treatment.

			A statement indicating that the estimate has been reviewed and understood by the patient.

			A statement indicating that the during the course of treatment, the treatment may need to be altered, due to unforeseen circumstances in which case options will be provided immediately along with any change in costs will be presented in writing.

			An expiration date for the cost of treatment (I recommend 90 days).

These, arrangements should be made in advance before incurring any expense. 

“The key is to communicate. I do not know of any dentist that would refer an account to collections if the patient simply informed them that they were having a financial hardship and made alternate arrangements. If an account gets so delinquent that it must be referred to a collection agency, there must have been a serious breakdown in communications,” Dr. Banker said.

Dental offices do have commercial financing options to offer their patients, for example, companies like CareCredit or Chase HealthFirst.

“They take the burden of collecting payments off of the dental office and allow the focus of their energy to be on the treatment.  In house financing can put a strain on the patient/doctor relationship. If a patient is unable to keep up with their agreed upon payments, it can put them both in an uncomfortable situation,” Dr. Banker said.

Cases involving consumer fraud claims can be protracted and nasty. This is not a medical malpractice case, so normal professional liability policies will not cover it.  Further, given the general public's current hostility towards finance firms, there is a risk to taking the case to a jury. Basically, this is a predatory lending case. Unfortunately, this type of case appears to be occurring more frequently.

• I recommend that the credit application be given to the patient without other documents. 
	
	• Don't hand the patient a stack of documents with an instruction to "sign these."  A separation in time from when the patient applies for the line of credit and when the professional services are rendered also helps.
	
	• Staff should be familiar with how the credit firm works to answer basic questions and should refer the patient directly to the financing firm for more specific information.
	
	• Finally, a little common sense should be used.  Don't present a credit application to a patient that is heavily medicated or is not in a condition to fully appreciate what they are signing.

With a little training of staff and appropriate procedures, a practice can go a long way to protecting itself from a predatory lend claim.    

Patty Ricard says in her years of consulting she finds that most dentists have no idea what their accounts receivable total is. She says they often leave it up to their front desk employees and hope who they have hired, know what they are doing. Problems often arise when more patient accounts are in red ink than in black.

“If accounts receivable are healthy it will take them less than five minutes to review a report because they are only going to have the accounts that were flagged the previous month,” Ricard said.

If a dentist's accounts receivable is not organized, then going through the effort of a review is even more critical. Socrates has been credited with saying “The unexamined like is not worth living.” The same can be said of your practice’s ledger. As margins shrink in this tough economy, you have little choice in addressing past due accounts.

Finally, take a moment to remind yourself why you are in the profession in the first place.
	 

It is nice to complete a patient's active treatment and see them for a routine checkup and cleaning.  Whether their treatment took 2 months or 2 years, they are so excited to hear that they don't need any new dental work. This is only attainable with good treatment planning and clear financial arrangements,” Dr. Banker said.

 is a partner with Sacopulos, Johnson & Sacopulos in Terre Haute, Indiana. He also serves as Legal Analyst for Dental Products Report, Plastic Surgery Practice and is National Counsel for Medical Justice Services, Inc.  His practice focuses on assisting healthcare professionals develop strategies and techniques to avoid medical liability claims.  He may be reached at 

Tips that all dental practices should use to set clear financial arrangements and expectations for their dental patients.

Maximize your dental practice's account receivable

	Social media can be used to connect with long lost friends and keep in touch with distant family members, but some dentists are using sites like Facebook to connect with their patients on a new platform.

	“I started using social media about two years ago when I opened up my own private practice as a tool to build community,” said Chicago based pediatric dentist Dr. Grace Yum.

	Dr. Yum says it has been a very useful tool for her practice. She says parents are posting questions on her business Yummy Dental Facebook page and other parents are answering the questions based from experience.

	“It has been a very useful tool for my practice because being in pediatrics, many parents have similar questions regarding their children and when they post; other patients can answer questions without me violating HIPAA regulations,” Dr. Yum said.

	Dr. Yum says when a patient sends her office a question over social media she replies and says this is not something I can answer over the internet. She asks her patients to feel free to call her by phone to conduct a private conversation.

	Yummy Dental’s Facebook page allows parents to show their kids what to expect when they get to their appointment.

	“They can get online and see what people say about us. They can see the photos posted. They can get to know us before they even get here, which is huge, because it is part of setting expectations. It is part of being believable and being familiar,” Dr. Yum said.

	Dr. Yum said she is also very careful about what she posts online.

	“I think it is pretty clear cut and a no-brainer on what photos you can post and can’t post,” she said. “If you think it is questionable then don’t post it. We keep it professional. We post photos that are all related to the office. We don’t post photos of our patients unless the parent gives consent.”

	For those who have questions on what they can and shouldn’t put online, The Ohio State Medical Association (OSMA) was the first medical organization to publish suggested guidelines. Jason Koma the Director of Communications and Marketing for the OSMA says physicians began calling several years ago asking for guidelines on how to communicate via social media. This promoted the OSMA to put together guidelines. Their tool kit was released in August of 2010.

	“There are every day real world questions that physicians face in 1) their own personal and professional lives and 2) within the office setting. It is helpful to have some sort of guidance to move forward,”Koma said.

	You can view OSMA guidelines at www.osma.org/socialmediapolicy. Below are a few starting guidelines for every practice to follow:

		Privacy rules apply online. Never disclose patient identifiable information

		Use appropriate disclaimers, consents and notices. Use HIPAA notice of private practices to address use of social media

		Confirm networking activities are compliant with: malpractice/insurance policies, professional society codes and hospital/medical staff policies

		Don’t send information that is fraudulent, harassing, embarrassing, sexually explicit, obscene, intimidating or defamatory.

	“Toolkits like this are just the first step to help physicians embrace and stay protected in an increasingly digital world,” Koma said.

	Avoid these simple guidelines at your own peril.  Dr. Alexandra Thran from Rhode Island in April of this year posted information about a patient on Facebook. Dr. Thran was careful enough to not release the patients name while using Facebook. But she typed enough unique information about the patient, that someone was able to identify the patient.   The Rhode Island Board of Medicine found Dr. Thran's posting to be “unprofessional conduct” for revealing a patient's personally identifiable information to third parties.

	Dr. Yum has about six other staff members and two doctors on staff. While Dr. Yum understands the risks with social media she only has a verbal social media policy for her staff.

	“The social media policy for our staff is basically not to be using it while at work. However I do have one team member on my staff that manages our social media so she kind of controls that while at work. So that way I know that the rest of the team is not using it for their personal gain or pleasure while at work. The policy is that you can only be on it at work if you’re responding to a patient or helping somebody else, “ Dr. Yum said.

	Dentists like Dr. Yum may want to revisit their practice's procedures. Just because staff are not involved with social media at work doesn't mean improper posting won't occur from home. Written policies are legally binding and make it easier to take action during a time of discipline. A written policy should include, but is not limited to the following:

		Employees and staff should agree to treat all information about the practice and patient care as confidential and will not disclose any such information to any third party without Physician’s written consent.

		Workers should refrain from directly or indirectly publishing or airing commentary upon Physician and his practice, expertise and/or treatment.

		Publishing is intended to include attribution by name, by pseudonym, or anonymously.

		Worker will work to prevent the publishing or airing of commentary about Physician from being accessed via Internet, blogs, or other electronic, print, or broadcast media without prior written consent.

		Worker will use all reasonable efforts to prevent any member of their immediate family or acquaintance from engaging in any such activity.

	Social media has become omnipresent and these guidelines are to help dentists as they seek to embrace or are dragged into what is a very different world in which we communicate today.

This work is copyrighted and is the exclusive property of the author. It may only be used, in whole or in part, with the express written permission of the author. 

	Michael J. Sacopulos is a Partner with Sacopulos, Johnson & Sacopulos, in Terre Haute, Indiana. His core expertise is in medical malpractice defense and third party payment disputes. Sacopulos is also the general counsel for Medical Justice. He may also be reached at 

 Social media can be used to connect with long lost friends and keep in touch with distant family members, but some dentists are using sites like Facebook to connect with their patients on a new platform.  “I started using social media about two years ago when I opened up my own private practice as a tool to build community,” said Chicago based pediatric dentist Dr. Grace Yum.

Trick or Tweet

Q: I have always worked on my children's teeth. Now they are grown and established with careers of their own with full benefits. I submitted a bill to my son’s dental insurance and was paid. A month later I received a request from a firm asking for a refund for the exam, prophy, and full mouth x-rays. The reason stated on the request for refund was that the insurance does not pay for work done by a family member. I could not understand why not so I called the number in the letter. The first person I explained the situation to told me this was not an uncommon situation. His recommendation was to bill under another doctor in the office and that was how other offices got around this. I felt the problem was the policy and I was not looking for a way to "get around the problem." 

Why was this policy permitted and accepted in the first place? The answer I got was that there were some health professionals that cheated in the past by billing for services that were not performed on their family members. To me this exclusionary policy implied guilt across all health care providers and seems wrong.

He referred me to another specialist in their office. She basically said the same thing but could offer no better justification for the policy. She later checked with a specialist in her office and told me that in my specific case, even if the other dentist in my office did the work I would not be paid because the dentist is an employee of mine and did not bill under another tax ID number. I was so frustrated by these policies so I asked specifically for copies of the written policies and the justification for them. She said she would send them but it has been weeks with no reply. The letter also stated that if the amount is not refunded by the now past deadline, they would take it out of future payments.

I am surprised by your question. I have not come across a third party payer that refuses benefits to a provider based upon family relationship. I agree that this policy seems silly and misguided. However, these type of payment issues are almost completely governed by contracts. Your son, I assume through an employer, has an insurance policy which provides dental benefits. That is one contract. A second contract is between your practice and the insurance carrier. Your practice may or may not have a contractual relationship with this insurance carrier. If either of these contracts prohibits an insured from receiving professional services from a relative then you may be out of luck.

You have done the right thing by asking for a copy of the policy/contract which prohibits you from treating your son. I would be surprised if they could produce this policy. Next, I would ask your son to take this issue up with his employer. Obviously the employer, who pays for this benefit, should be able to get the attention of the insurer. If your son works for a larger employer, he should speak to the Human Resources department about this situation. If it is a smaller entity he may be able to speak to the agent that sold the coverage to his employer.

A final word of advice, I would not devote much more effort to the situation right now. You have been paid and still have the money. Should they attempt to offset future work to recover money from your son’s services, then I would take action. Your son can exert some leverage via his employer. If you do not have policy language by the time they pull back funds I would turn the carrier into your state department of insurance. I have also had some success in filing small claims against third party payers under the theory you are a beneficiary of the insurance contract. This may be more trouble than it is worth to you, but it usually has the desired effect. I wish you all the best with this and please let us know how the story ends.           

How do you best handle divorced parents with varying and sometimes changing custody agreements?

Unfortunately, payment issues for minor children of divorced parents come up frequently. Often times a divorce decree will specify which parent is responsible for medical/dental expenses for a child. You need to know that this divorce decree is effective between the former spouses and does not impact your practice. You are not listed on the court order, just the two former spouses. In most states, the law is that both parents are equally responsible for their child’s medical care. This raises the situation that one parent may pay for the care, but the other is responsible for reimbursing him or her. I suggest you contact a local attorney to determine if your state has a statue imposing financial liability on both parents for their child’s medical care.

In most states, there is a distinction between legal custody and physical custody of a child. Physical custody is most often referred to as visitation. Legal custody issues are referred to as either joint custody or sole custody. Issues related to physical custody are less important to you as a dental provider. The legal custody has significance for who you can discuss a child’s dental health issues with. If there is joint custody over the child, you may speak to both parents about confidential dental issues regarding the child. However if one parent has sole custody you will not be able to speak to the non-custodial parent about your patient’s dental issues. Again this distinction is provided as a general overview. State laws vary and you may wish to run this past your local attorney.

Q: I have always worked on my children's teeth. Now they are grown and established with careers of their own with full benefits. I submitted a bill to my son’s dental insurance and was paid. A month later I received a request from a firm asking for a refund for the exam, prophy, and full mouth x-rays. The reason stated on the request for refund was that the insurance does not pay for work done by a family member. I could not understand why not so I called the number in the letter.

Ask the Lawyer

	Waiting to see the dentist can be trying. There are only so many magazines one can read. Now, dentists like John Stark in South Jordan, UT are providing iPads to patients in the waiting room. The iPads are loaded with dozens of easy to use apps, most of which pertain to dental health.

	“Patients love it, it has been pretty amazing how people will play with it,” Dr. Stark said.

	According to a 2010 market research report by Research and Guidance, 500 million smartphone users will be using a healthcare application by 2015. Consumers are utilizing these tools almost as quickly as they can be developed. There are apps to allow individuals to monitor their calorie intake for healthy weight management, and apps for physicians to view patients x-rays on their mobile communications device.

	On the clinical side Josh Berd, DDS in San Francisco loves using the app “DDS GP."  The application's library contains a series of presentations that span all topics in dentistry. For example Dr. Berd explains that if a patient needs a filling he can show a video on how cavities are formed.

	“If you need a root canal, the app will show you how it is done so you simply don’t have to use your imagination,” Dr. Berd said.

	Dr. Stark also prefers using the “DDS GP” app in his practice. Before he would find himself drawing on paper to explain a procedure, now he uses an i-Pad.

	“In dental, trying to explain a procedure to a patient is difficult, they don’t have any context to what we are doing,” Dr. Stark said.

	But some of the apps used by Dr. Stark and other may soon be regulated by the FDA. The FDA has publically stated they are encouraging the exciting development of new applications that can make healthcare better. On the other side of the coin the FDA also says they have a public health responsibility to oversee the safety and effectiveness of those mobile medical applications that present a potential risk to patients if they don’t work as intently.

	“At this time we haven’t received any reports of problems related-specifically to mobile medical applications. We do usually expect to under reporting in devices in general. And perhaps with great, you know, we may see an increase in the number of reports with this increased awareness in the guidance,” Associate Director for External Communications for FDA’s Center for Devices Peper Long said in a recent interview.

	The FDA has released a proposal for regulating mobile medical applications or mobile medical apps. The FDA is seeking input on its proposed oversight approach for certain mobile medical applications specific to medicine or healthcare called Mobile Medical Applications, which are designed for use on smartphones and other mobile commuting computing devices. The FDA says they are focusing on only a select group of applications, and will not regulate the sale or general consumer use of smartphone or tablets.

	“In order to provide manufactures of such mobile medical applications with the clear understanding for which mobile medical applications the FDA will oversee. The FDA has defined a small subset of mobile and medical applications that may impact performance or functionality of currently regulated medical devices,” Policy Advisor from the Office of the FDAs Center for Devices Bakul Patel said.

	The FDA’s definition includes mobile medical applications that are used as an accessory to a medical device, already been regulated by the FDA. One example of this is an application that allows a healthcare professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system, also known as PACS, on a smartphone or mobile tablet. Another example is an app that calculates a patient’s Glasgow Coma Score based off of physician inputs.

	The definition will also include a mobile medical application that can transform a mobile communication device into a regulated medical device by using attachments or sensors. Here an example is an application that turns a smartphone into an ECG machine or an electronic stethoscope to detect abnormal heart rhythms or determine if the patient’s experiencing a heart attack will be considered under this definition.

	“We believe this outline approach does not cover the majority of mobile applications and will continue to promote innovation in this new and expanding field,” Patel said.

	The FDA is encouraging feedback from manufactures, healthcare providers, and other stakeholders in how this proposal will support the balance between promoting innovation and ensuring safety and effectiveness. One can submit an electronic comment to 

	“This is necessary. The FDA, medical and dental communities have to be involved,” Dr. Berd said.

	At this time the FDA does not have an enforcement game plan for approaching an app manufacturer if the app does not work up to par.

	“I think we will be able to look at it on a case by case basis and we would enforce as it’s appropriate. I don’t think a blanket statement would work in any particular situation including currently regulated medical devices,” Patel said.

	“If there is an app that is going to make you more efficient or better connected with your patients or even your staff than why not?” Dr. Berd said.

	It is a question that the FDA plans to continue sorting through in the upcoming months.

Michael J. Sacopulos is a Partner with Sacopulos, Johnson & Sacopulos, in Terre Haute, Indiana. His core expertise is in medical malpractice defense and third party payment disputes. Sacopulos may be reached at mike_sacopulos@sacopulos.com.    

 Waiting to see the dentist can be trying. There are only so many magazines one can read. Now, dentists like John Stark in South Jordan, UT are providing iPads to patients in the waiting room. The iPads are loaded with dozens of easy to use apps, most of which pertain to dental health.  “Patients love it, it has been pretty amazing how people will play with it,” Dr. Stark said.