Digital Legal & Compliance
Guidance
Guidance
Healthcare has leapt out of the brick-and-mortar into the digital, online, mobile, and virtual space. Our digital healthcare lawyers advise digital health leaders on regulatory pathways to market, compliance issues, and transactions involving the ever-expanding reach of healthcare technology into our physical lives.
Who Uses Digital Health
With fitness trackers and health data embedded in our smartphones, digital health is now within the reach of almost every consumer. Digital health is now a central component of the sports and fitness industry. The lines between medicine and general wellness are blurrier than ever, with digital health leveling the landscape as to who can provide services. As well, digital health is not only the province of healthcare technology companies, but also of healthcare professionals. For example, we have represented a variety of healthcare providers who have developed an app for their patients, or, expanded their practice into either telemedicine or mobile healthcare.
These providers can include:
- Chiropractors and acupuncturists (DCs and LAcs)
- Dentists
- Optometrists
- Physicians (MDs and DOs)
And a variety of other healthcare businesses, such as elder care clinics, hospitals, medical spas and beauty-oriented services, veterinary practices, and others, also use the digital health space to provide value-adds to their clientele.
The Digital Healthcare Legal Landscape
Digital healthcare represents untold opportunity for healthcare startups and entrepreneurs. With healthcare insurance companies not only accepting, but in some cases, requiring that insurance consumers use fitness trackers and provide data relating to their daily health and wellness, digital health is not only mainstream but also a part of the financial architecture of healthcare. And, this means that health and wellness is no longer the sole and exclusive domain of the healthcare professional or of ancillary business (such as MSOs) that service healthcare providers. Rather, online companies (and digital empires) are rushing into the competitive landscape that is converting healthcare professional services, into digital products.
We understand that increasingly, personalized medicine is the only form of healthcare that patients will accept. The days of what we call “cookbook, conventional medicine” are over.
The legal issues our healthcare and FDA lawyers address with digital and mobile health startups and established companies include:
- Agreements between the digital health company and the healthcare providers
- Analysis of state laws relevant to digital, mobile, and connected health
- Drafting consumer disclosures
- Financing from private, institutional, and venture capital for digital healthcare and life sciences companies
- Formation of the digital health company
- Intellectual property (IP) protection of digital and mobile health assets
- Joint ventures and strategic alliances involving digital healthcare ventures
- Mergers & acquisitions (M&A) of digital healthcare companies
- Privacy and security issues, including drafting and review of business associate agreements, HIPAA compliance, data protection
- Regulatory due diligence
- Review of FDA regulatory issues such as, for example, FDA regulations related to mobile medical apps and general wellness devices; the CURES Act; and regulation of medical devices
- Strategic agreements involving technology transactions, licensing agreements, and other transactional documents
- Strategic counseling on overcoming regulatory barriers to innovative product and service lines
- Terms of Use for the digital health company’s website, with appropriate legal disclaimers
See also our Services page on Telemedicine Ventures.
We operate at the forefront of cutting-edge advances in health and medicine, whether they involve genetics, robotics, machine learning and artificial intelligence, virtual reality, nanotech, software, or other technologies.
FAQ
Great! Let us know and we’ll do a conflicts check and then send you an engagement letter. Typically we want to know if we are going to represent you as an individual, or your entity (corporation or LLC); we’ll also want to know your website and some basic contact information.
Review our legal services to see some of the areas we like to work in; check our testimonials, client roster, and experience; read some of our blog posts; check out our Linked In community; or just call or email us to explore. Put simply, we represent health and wellness products, technologies, practices and ventures that accelerate health and healing.
We are very comfortable working with clients via phone and email. You can sign, scan and email the engagement letter, and submit the advance by check or online.
The answer depends on the complexity of the project. Each client’s situation is different. We want every client to receive the best possible advice, and so we want to be in a position to devote as much time as is required to do that. Look to our testimonials, client roster, and experience. We work with our clients effectively and efficiently and build long-term relationships based on mutual trust. We bill hourly and do not offer project or flat fees. Lawyering is an art, not a science – we’re intuitive as well as skilled lawyers.
Yes, like most law firms, we require an advance against fees and costs. Our typical advance ranges from $3,500 – $10,000. We offer our expertise and savvy and work hand-in-hand with you toward your goals. Occasionally, we will offer you a one-hour consult as a way to jump-start our work together, and give you an overview of critical issues, with guidance on the critical business cross-roads you’re facing. We do not take equity or deferred compensation.
Our Firm doesn’t quite “quotes” or answer “how much does it cost.” Through long experience, we’ve found that the answer is pretty much meaningless. Some lawyers and law firms give quotes, but if you read the accompanying disclaimer, you’ll see that the disclaimer basically says that you can’t depend on the quote for anything. In our long experience, “how much it costs” depends on a lot of variables, including:
- What the client is asking for
- What the client really needs
- What the client doesn’t know they don’t know
- What we discover as we dive into the legal research and analysis
- How complicated the problem really turns out to be
- How much client will want to do on their own
- Whether we can find some elegantly simple solutions to sub-parts of the puzzle
- What decisions we make together, and separately, as we explore the puzzle and put solutions and strategies together
In many cases, we might think a project is very complex but then as dig in, we can make executive decisions and recommendations that save the client dozens of hours of lawyer time and tens of thousands of dollars. This happens a lot with our clients. In other cases, the client might think the problem is simple but as we start to review it, the puzzle is much larger; sometimes the client throws in extra facts and complications at the last minute, and that will increase the expense and work; sometimes we’ll give the client “homework” so they can DIY a piece, taking it outside the need for lawyer time.
One thing we do is get our clients frequently on the phone. We find that the Legal Strategy Session often cuts through the fog. Where we need to do a chunk of written legal work, we’ll do so and let you know that’s what we think is needed. Where we can be more efficient with a call, we’ll tell you that as well.
Many clients come us after having wasted tens of thousands of dollars with other lawyers. Read our testimonials. We’re here to provide a lot more value than the retainer—our business model and Firm policy is to provide at least 3-5 times the value back to you. That’s our model and we’re sticking to it. We’re not trying to sell you on a “cheap retainer” or promise of discounts. We’re here to solve a big hairy problem and get you where you need to go, as efficiently and productively as we can.
Typically, assessing feasibility involves legal and strategic advice, which we provide in the 45-minute consult, in a way that is appropriate to the time we have together there.
The only way to know is to jump into the process. If you want to know more about us and how we work, browse our testimonials, look at our client rolodex, or review our experience on our website.
Work with us and find out how efficient and engaged we are with your business. We like to work with clients for life. It is a deep and trusting relationship.
Michael’s bio is online here. He has written books on healthcare law and policy, taught healthcarelaw as a faculty member at Harvard Medical School, garnered NIH and other medical research grants, and published over 100 articles in legal and medical journals. Michael speaks all over the world on healthcare topics.
