The Top 5 Legal Concerns When Developing a Healthcare App Print E-mail
Written by Steven Boyne   
Thursday, 25 June 2020 08:36

Today no one can live without a smart phone, and we interact with the rest of the world through a series of apps that reside on our handheld devices. From the healthcare perspective many large healthcare institutions and private companies have developed a myriad of healthcare related apps that currently reside in Apple’s App Store and  Google's Play Store. You can measure your heart rate, get clinical advice, view your records, check on your health insurance coverage, make appointments and virtually interact with many different types of healthcare providers. But even in today’s hyper-electronic society it took COVID-19 to really cause an explosion in telehealth, so what does that tell us? There is a lot more room for expanding electronic interactions with patients and clients through Apps. So, here are the top five legal concerns should you address when you develop a Healthcare App:
  1. HIPAA.It is very likely that no matter the type of healthcare app, HIPAA will be a concern. Even such a benign act as capturing an email address to allow a person to set up an account could be covered under HIPAA.  There are many ways to mitigate or minimize your exposure to HIPAA, but don’t rely on your App developer to make sure you are safe. The key is to understand the flow of data between the end user and your company and plan ahead.  It is much easier to build in the appropriate protections and design your app from the beginning with the necessary HIPAA security and disclosures, rather than wait until you realize you may have inadvertently breached some HIPAA rule or regulation.
  2. State and Foreign Privacy Laws. Don’t forget Apps can be used from anywhere in the world and end-users will live or travel to many states and countries. To minimize your financial, regulatory, and legal risks you need to examine the planned type of App, where your company is based, whether you have offices in multiple locations, states or countries, and the type and volume of data that you may be providing or gathering. Other privacy concerns may come into play depending on what the user can do with the information on their screen, like forwarding, taking a picture, or posting something on a social media site.
  3. Who is the End-User. At first blush it would seem a stupid question, the end-user is the person that owns the phone and has downloaded the App. Not so. What if the owner of the phone allows someone else to use their phone, and that person now has access to your patient’s private and personal health records? Do you have liability? To minimize these problems, you may need to think about upfront security before the user can access their own data; or you may need to draft appropriate disclosures that the end-user may have to agree to when they first download the app.
  4. Sales Tax. If you are planning on marketing and selling healthcare related items, you should be thinking about Sales Tax. For example, just because you may be based in State where medical equipment is not subject to sales tax, or has a lower tax rate, doesn’t mean that you are set.  The purchaser could live in a different state, and even ship the items to a third state, so you should understand, plan for, and capture the correct information so you can collect and remit the right dollars to the appropriate taxing authorities. 
  5. Understand the Healthcare Regulatory Environment. Beyond state, federal and international privacy laws there are many regulators that have authority over healthcare. By developing an App you maybe interacting with people all around the world, and you should be aware that it is quite likely that the App may make you vulnerable to regulators that you have never had to deal with before.  Furthermore, even if you are regulated, the use of an App may expand that regulator’s power over you. For example, if you are regulated by the FDA and you create an App to essentially move the same business to the internet, well now the you have to comply with a whole new set of FDA rules.  Some Apps may need to be certified by independent third-parties, and other types Apps may now cause your business to be subject to the Federal Trade Commission’s Rules and Regulations. In short, plan for different types of regulators and regulations.
All of this may seem overwhelming at first, but identifying your risks, the flow of data, and early planning at the front end will save you lots of money and future heartache. As Benjamin Franklin said: By failing to prepare, you are preparing to fail.
About the Author: Mr. Boyne is an attorney with the Florida Healthcare Law Firm in Delray Beach. You can learn more about Mr. Boyne HERE and view more health law articles on the firm's blog page HERE.

Last Updated on Thursday, 25 June 2020 09:27
People are getting sick from coronavirus spreading through the air – and that's a big challenge for reopening Print E-mail
Written by Douglas Reed Associate Professor of Immunology, University of Pittsburgh   
Wednesday, 17 June 2020 18:09

I am a scientist that studies infectious diseases and I specialize in severe respiratory infections, but I also serve as a member of my church’s safety team.

Over the past few weeks as states began to loosen restrictions, we have been discussing if and how to safely start services again. But the coronavirus is far from gone. As we try and figure out how to hold services while protecting our members, one question is of particular concern: How common is airborne spread of the virus?

How to spread a virus

Respiratory infections are generally spread in three possible ways: from direct contact, from droplets and from airborne particles.

Contact transmission occurs when a person touches an object that has live virus on it – called a fomite – and gets sick.

Droplets are small particles of mucus or saliva that come from a person’s mouth or nose when they cough or talk. They range in size from 5 microns to hundreds of microns in diameter - a red blood cell to a grain of sand. Most droplets, particularly large ones, fall to the ground within seconds and don’t usually travel more than 1 or 2 meters. If a person coughed on you and you got sick, that would be droplet transmission.

Airborne transmission happens because of airborne particles known as droplet nuclei. Droplet nuclei are any bit of mucus or saliva smaller than 5 microns across. People produce droplet nuclei when they talk, but they can also be formed when small droplets evaporate and shrink in size. Many of these droplets shrink so much that they begin to float before they hit the ground, thus becoming aerosols.

People produce thousands of these droplet nuclei per second while talking and the aerosolized particles can contain live viruses and float in the air for hours. They are easy to inhale, and if they contain live virus, can get people sick. The ability of droplet nuclei to transmit the coronavirus has a massive impact on if and how places like my church can reopen.

Early on in the pandemic, experts at the Centers for Disease Control and Prevention and the World Health Organization were most concerned about the coronavirus being transmitted from surfaces and from large droplets.

But the more research is done on SARS-CoV-2, the more evidence there is that airborne transmission is occurring although it is controversial. Both the CDC and WHO are now recommending that the general population wear masks, but for people going about their lives and wondering how to reopen public areas across the world, the question remains: Just how important is airborne transmission?

Airborne longevity in the lab

To get infected, a person needs to come in contact with live virus. If the virus dies before a person can inhale it, they won’t get sick.

To test how well SARS-CoV-2 can live in the air, researchers use special equipment to create aerosolized virus and keep it airborne for long periods of time. Researchers can then take samples of the virus and see how long it stays alive in an aerosol. An early study from researchers at the National Institute of Health kept the virus airborne for four hours and found live virus the whole time. A subsequent pre-print study that I was part of found that the coronavirus can stay alive for up to 16 hours in the air.

Neither the initial study nor the one that I was involved with measured the impact of temperature, humidity, ultraviolet light or pollution on survival of the virus in aerosols. There is evidence that simulated sunlight can inactivate 90% of SARS-CoV-2 viruses in saliva on surfaces or in aerosols within seven minutes. These studies suggest that the virus would be rapidly inactivated outdoors, but the risk of transmission indoors would remain.

Evidence from the real world

Laboratory studies can provide valuable insight, but real world scenarios point to the true risk from airborne transmission.

Reports from China, Singapore and Nebraska have found the virus in patient rooms and at very low levels in the ventilation system of hospitals where COVID-19 patients were treated. The report from China also found evidence of the virus at the entrance of a department store. So far, this sampling has been done using polymerase chain reaction tests which look for pieces of viral DNA, not live virus. They can’t tell researchers if what they are finding is infectious.

For direct evidence of the risks of airborne transmission, we can look to a few case studies in the U.S. and abroad.

One study tracked how a single infected person at a call center in South Korea infected 94 other people. There is also the widely reported of case of one infected person at a restaurant in Guangzhou, China, spreading the virus to nine other people because of the airflow created by an air conditioning unit in the room.

Perhaps most striking, especially for myself as we contemplate how to reopen our church, is the example of the church choir in Skagit County, Washington. A single individual singing at a choir practice infected 52 other people. Singing and loud vocalization in general can produce a lot of aerosols, and evidence shows that some people are super-emitters of aerosols even during normal speech. It’s likely that some infections in this incident occurred from droplets or direct contact, but the fact that one person was able to infect so many people strongly suggests that airborne transmission was the driving factor in this outbreak.

A paper published just last week compared the success of mitigation measures – like social distancing or mask wearing – to try and determine how the virus is spreading. The authors concluded that aerosol transmission was the dominant route. This conclusion is hotly debated in the scientific community, but this study and others do show the effectiveness of masks in slowing the spread of COVID-19.

What does this mean for reopening and for individuals?

The evidence strongly suggests that airborne transmission happens easily and is likely a significant driver of this pandemic. It must be taken seriously as people begin to venture back out into the world.

Thankfully, there is an easy, if not perfect way you can reduce airborne transmission: masks. Since people can spread the virus when they are pre-symptomatic or asymptomatic, universal mask wearing is a very effective, low-cost way to slow down the pandemic.

Since the primary risk is indoors, increasing ventilation rates and not recirculating air inside buildings would remove the virus from the indoor environment faster.

My church has decided to reopen, but we are only planning to allow limited numbers of people in the church and spreading them throughout the sanctuary to maintain social distancing. And at least for now, everyone is required to wear masks. Especially while singing.

[You need to understand the coronavirus pandemic, and we can help. Read The Conversation’s newsletter.]The Conversation

Douglas Reed, Associate Professor of Immunology, University of Pittsburgh

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Last Updated on Wednesday, 17 June 2020 18:27
Healthcare Heroes: Yes, Pandemic Lawsuits Will Become Viral Print E-mail
Written by Matt Gracey   
Thursday, 21 May 2020 09:06

What a spicy, hot pandemic stew of lawsuits is brewing in America! This is particularly true in the healthcare world since this is a mother lode of a healthcare crisis.

Simmering now and headed to a boil are incredibly strong factors: Fear; sadness; isolation; divisiveness; suspicion; and distrustfulness of authority, of others, of scientists, of doctors, of politicians, of neighbors, of darn near everyone.

Throw in a predicted unemployment rate up to 30%, with over 36 million already out of work.

Add an economic downturn second only to the Great Depression. Economic desperation drives many lawsuits.

Sprinkle in a healthcare system very much based on employer-supplied coverage that has mostly now been terminated for the unemployed, disrupting long-term doctor / patient relationships, the best of which are the foundation of successful risk management to avoid being sued.

Add a bitterly politically divided country with a hotly contested election for our top elected positions.

Stir in a hundred-year pandemic for which we are ill prepared, as we fumble for swift, effective, coordinated responses.

Fold in a judicial system that judges doctors according to “standards of care” at a time when few standards, besides washing our hands frequently, are even agreed upon.

Overlay that now-boiling stew with the most highly litigious culture in the world, in a country that produces vast quantities of lawyers every year, with plaintiff and class-action-happy lawyers chasing dog-bite cases with billboards, mass emails, and doctors’ mistakes with letters of intent to sue.

Then throw all of that into a very-hot oven for an undetermined amount of time with highly educated doctors risking their and their families’ lives every day to help their patients.

See why we are concerned about what doctors are facing on the other side of this hot pandemic kitchen we call America?

Start now – protect your practice and yourself! Work on strengthening every one of your patient relationships, be empathetic, and be great with your communications, documentation, and expressions of care and concern. Review your med mal coverage with an expert. Dust off every risk management technique you have learned.

Most of all, remember that you are a hero and are loved.

Matt Gracey is the CEO of Danna-Gracey, a medical malpractice insurance agency in Delray Beach.

Last Updated on Thursday, 21 May 2020 09:29

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