The weather has cleared and SXSW is well underway! The HBInnovate team has been sharing its experiences via Twitter and blog, keeping everyone up-to-date on the innovations and creative ideas on display.

Hot at SXSW continues to be healthcare products and services that rely upon a phone or tablet. Everyone sees the tremendous potential phones and tablets have in supporting our health and wellness.  One of the most common concerns from healthcare startups has been how to do roll-out products and services compliant with The Food and Drug Administration (FDA).

Continue Reading SXSW 2017 –Dare Enter the World of the FDA?

Given the transformations taking place at every level in healthcare, it is no surprise that the 2017 SXSW Interactive Conference has a big spotlight on the industry. One superstar in the spotlight this year is wearables. The accelerator pitches during SXSW include ones for wearables designed to improve prenatal care and early breast cancer detection, and there is even a presentation on brain wearables to detect stress, improve focus, and even to let you play video games with your brain. That’s right, brain wearables that help you focus and let you play video games.

Continue Reading Continued Coverage of the SXSW Interactive Conference, Health Track – Accuracy: Consumer Wearables and Academic Research

Medicine and new technologyA little rain can’t stop SXSW. Husch Blackwell attorneys have attended dozens of interesting presentations and met countless innovative minds. We will continue to post live updates on Twitter (@HBhealthcarelaw) and release brief blog posts related to certain presentations throughout the event. With former VP Joe Biden in town to discuss his cancer moonshot today, our focus is precision medicine.

Precision medicine is an innovative approach to medical treatment that takes into account individual differences in people’s genes, environments, and lifestyles. The promise of precision medicine is delivering the right treatments, at the right time, to the right person. The potential of precision medicine is recognized at the highest levels of government. In his 2015 State of the Union address, former President Barack Obama launched the Precision Medicine Initiative (“PMI”), a bold new research effort to revolutionize health and the treatment of disease. Subsequently, Sylvia M. Burwell, Secretary of the U.S. Department of Health & Human Services (“DHHS”), announced the FY 2016 budget would include $215 million for the PMI, with $200 million of this to be used by the National Institutes of Health (“NIH”) to launch the All of Us program, a national cohort of a million or more Americans who volunteer to share genetic, clinical, and other data to improve research. The funds will also be used to invest in expanding current cancer genomics research and to initiate new studies on how a tumor’s DNA can inform prognosis and treatment choices.

Continue Reading Precision Medicine – The All of Us Program

cellphone137457731Today kicks-off one of Austin’s largest and best-known events, the South by Southwest Interactive Conference. In the spirit of Husch Blackwell’s involvement in several aspects of the conference, this post will touch on emerging health technology and pushing the limits of HIPAA.

New technology is being developed to be used in healthcare settings on a near daily basis. Telehealth, mobile apps, medical devices, implantables, robotics, electronic health records, e-prescriptions, digital pills, and wearables are just a few of the innovations that contribute to a patient’s treatment. There are more ways for people to access medical care, and more ways to produce and share patient data with healthcare providers than ever before. At some point in the development stage, you and your team probably asked questions like these:

  • What data are we collecting? Where do we keep it?
  • How can we use it? How can we not use it?
  • Who owns it? Can we own it?
  • Does HIPAA apply to us?
  • Are there other laws we need to worry about?
  • What if we lose some data?

First things first, a quick primer on HIPAA, the law you’re likely generally aware of.  HIPAA is comprised of a privacy component and a security component. The HIPAA privacy rule addresses the confidentiality of certain health information and the HIPAA security rule sets basic security standards for certain health information held or transferred in electronic form. These regulations apply to covered entities and their business associates. Generally, a covered entity is a health plan, a healthcare clearinghouse, or a healthcare provider. A business associate is an individual or entity that creates, receives, maintains or transmits PHI in the course of performing services on behalf of a covered entity. Basically, PHI may not be used or disclosed by a covered entity (or a business associate on its behalf) without patient authorization unless an exception applies. One frequently cited exemption relates to the use and disclosure of PHI necessary to carry out treatment, to obtain payment, or to conduct healthcare operations. When PHI is shared between a covered entity and a business associate the parties execute a business associate agreement that governs the business associate’s use and security of PHI.

Innovative technology is pushing the limits of HIPAA. Companies may encrypt and store data for a covered entity but never have access to it, and companies may act purely as a conduit to connect two hospital systems sharing data but never store or alter the data in any way. Should companies like this be subject to HIPAA?  This is a point of contention that the government is trying to clarify.  This has been done through guidance issued by Health and Human Services addressing the application of HIPAA to cloud service providers (found here). Further, the OCR has developed an online privacy and security portal for mobile app develops (found here) and HIMSS has developed a mobile health security kit (found here). It will be important to remain aware of further guidance that may be issued by multiple government agencies.

But what if you’re not a covered entity and you don’t have a relationship with a covered entity that makes you a business associate? Just because you have access to a medical data does not necessarily mean HIPAA applies. When someone buys a Misfit fitness tracker off the shelf, the data collected by the wearable is not protected by HIPAA. However, if a person receives a wearable from their physician to track certain data, that information likely is protected under HIPAA. This is an important distinction.

So if HIPAA doesn’t apply, what does?  The Federal Trade Commission (FTC) has issued the Health Breach Notification Rule to require certain businesses to notify their customers if there’s a breach of unsecured, individually identifiable electronic health information. This applies to any entity that is not subject to HIPAA, but collects or maintains identifiable health information on an individual. Further, the FTC is becoming very active in enforcing its consumer protection laws against companies for misrepresenting how an individual’s data is used or a company’s failure to adhere to its own data use and protection policies.
Finally, states are able to establish rules more stringent than HIPAA so it is very important to take such laws into consideration. A state may expand the definition of a covered entity or business associate, and may have its laws apply to any entity that has access to the health information of a resident of the state. This may mean that the laws of a state where you don’t have a physical location may apply to you through the data you collect.

If you have any questions about what privacy laws may apply to your operations, please feel free to contact me directly at (214) 999-6132 or john.ferguson@huschblackwell.com.

flag_160540827On Monday, March 6, 2017, House Republicans released the long awaited proposed legislation to replace the Affordable Care Act (ACA).

The GOP bill, the “American Health Care Act” (AHCA), repeals or significantly changes major portions of the ACA involving the individual and employer mandates, subsidies, and Medicaid expansion, among others. The AHCA, which is already facing political headwinds and healthcare industry objections, has not yet been scored by the Congressional Budget Office (CBO), so the economic effect and the potential change to the number of people covered by health insurance have not been officially quantified. However, the AHCA’s overall philosophy and goals are clear, and it signals areas of concern for healthcare providers and Medicaid expansion States. In this article in our series on the effect of a “slow repeal” of the ACA, this week’s discussion focuses on the significant aspects of the proposed AHCA, potential concerns for healthcare providers, and likely next steps.

Continue Reading Slow Repeal of the ACA – Proposed Replacement Legislation Released

flag_160540827This is the seventh article in our series on the effect of a “slow repeal” of the ACA. This week’s discussion focuses on the potential impact on healthcare technology.

Industry experts are predicting that a slow repeal of the ACA will have very little, if any, negative impact on healthcare technology. Healthcare technology grew at an unprecedented pace under the ACA, in part because the ACA contains provisions which provide healthcare technology with incentives to develop and implement new systems aimed at increasing efficiency. Despite the significant amount of uncertainty with a slow repeal of the ACA for many players in the healthcare industry, healthcare technology appears to be poised for continued growth through value-based care, telemedicine, and the increased need for interoperability.

Continue Reading Slow Repeal of the ACA and Its Effect on Healthcare Technology

Earlier we wrote that two Fifth Circuit cases seemed to reach inconsistent determinations about the availability of punitive and pain and suffering damages under the FLSA and ADEA. The Fifth Circuit previously expressed its intent to interpret the remedies provision under the FLSA and ADEA consistently with each other. Please see our discussion at via our January 13 blog post.

One of those opinions has been withdrawn and a new opinion substituted, but the inconsistency remains, The Vaughan v. Anderson Regional Medical Center decision was first issued on December 16, 2016 (we discussed the first issued version in our prior post). But because the opinion contained some manifest inconsistencies with the Pineda v. JTCH Apartments, LLC opinion issued just three days later, the plaintiff in Vaughan requested a rehearing en banc. Although the court denied the petition for a rehearing en banc, the court withdrew the prior opinion and substituted a new opinion. The new Vaughan opinion reaches the same ultimate conclusion and holding as the prior opinion, but it contains a few revisions that make clear its holding on ADEA remedies does not extend to FLSA remedies. But still, the two panels did not interpret remedies available under the ADEA and the FLSA consistently.
Continue Reading In the 5th Circuit, Pain and Suffering and Punitive Damages Recoverable under FLSA, not ADEA

flag_160540827This is the sixth article in our series on the effect of a “slow repeal” of the ACA. This week’s discussion focuses on the potential impact on post-acute care providers.

The term “post-acute care provider” encompasses a large and diverse group of healthcare providers that includes nursing facilities, home health agencies, hospice agencies and assisted living communities. While each group has its own very unique industry characteristics, they all have at least one thing in common: none of them rely, to any great extent, on private insurance as a form of payment. This is because the vast majority of the patients served by post-acute care providers are older than 65 and, accordingly, are covered by Medicare. So, any repeal efforts relating to the private insurance exchanges that expanded healthcare coverage for more than 30 million Americans will have minimal impact on post-acute care providers. Instead, the key issue facing post-acute care providers relating to the slow repeal of the ACA is the threatened conversion of Medicaid into a block grant program. Continue Reading Slow Repeal of the ACA and Its Impact on Post-Acute Care Providers

Texas_157051216In addition to H.B. 307 (discussed in a prior post), H.B. 1566 and its companion bill, S.B. 507, propose to expand the requirement for mediation of balance bills.

Currently, Chapter 1467 of the Texas Insurance Code requires a facility-based physician to mediate balance bills upon the request of the patient if the patient is responsible to a facility-based physician, after copayments, deductibles, and coinsurance, including the amount unpaid by the administrator or insurer, for an amount greater than $500 and either (i) the facility-based physician fails to disclose projected amounts for which the patient may be responsible and the circumstances under which the enrollee would be responsible for those amounts; or (ii) the facility-based physician makes the disclosures but the amount billed is greater than the maximum amount projected in the disclosure. Continue Reading Texas 85th Legislature (2017) Legislation Update: Out-of-network billing limitations

flag_160540827This is the fifth article in our series on the effect of the “slow repeal” of the Affordable Care Act (ACA). This week’s article focuses on the potential impact of the slow repeal of the ACA on rural communities and healthcare.

Continued Fragile System Leads to Uncertainty or Closure Causing Economic Ripple Effect Throughout Rural America

There are nearly 5,000 short-term, acute care hospitals in the United States, half of which are in rural areas. About four in 10 rural hospitals are located in the South. More than half of rural hospitals are Critical Access Hospitals (CAHs) (53.5%); a smaller share of rural hospitals are designated as Sole Community Hospitals (SCHs) (13%), Medicare Dependent Hospitals (MDHs) (8%), and Rural Referral Centers (RRCs) (11%). All of these designations provide enhanced or supplemental reimbursement under Medicare, using different formulas. Rural hospitals that do not qualify for these Medicare programs are reimbursed as standard Medicare Prospective Payment System (PPS) hospitals. Continue Reading Slow Repeal of the ACA and Its Impact on Rural Healthcare and Communities