Digital & Mobile Health Companies

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.