Health Care Reform – Legal – Part 3: Longevity & Anti-Aging Medicine, Genomics, Robotics, Nanotechnology, and The New Healthcare Legal Landscape

Healthcare reform—aka “Obamacare”—changes much of the financial, tax, and insurance landscape for healthcare. However, it leaves huge swathes of healthcare law untouched. This is because:

  • The whole drive for “universal access” to healthcare largely concerns itself with financial and insurance issues—questions of cost and who will pay for what. As a byproduct of these concerns, healthcare reform addresses quality of care, and consumer choice. And there is some attention to prevention and wellness. But health, wellness, and lifestyle, and even medicine, are such broad arenas of activity that the Affordable Care Act is in some senses more limited in its reach than most people imagine.
  • Much of healthcare is regulated by state law, and the Affordable Care Act is a federal statute which changes federal law.

For example, here are some areas of law that federal healthcare reform does not explicitly address:

  • The standard of care in clinical decision-making. Medical standards of care are set by physicians. In a medical malpractice (negligence) action, the plaintiff brings an expert to testify as to the standard of care. The legal rules governing medical malpractice vary by state. They are not creatures of federal law. As medicine evolves, so do standards of care.
  • Integrative models of care that incorporate conventional medical doctors, allied health professionals (such as dentists, nurses and psychologists), and complementary and alternative medicine (CAM) providers (such as chiropractors, acupuncturists, naturopathic doctors, and massage therapists). The Affordable Care Act focuses on economic integration, not on clinical integration of varying camps of healthcare professionals. Future medicine, including anti-aging medicine, longevity medicine, nanotechnology in medicine, emerging biotech, genomic nutrition, and other emerging scientific breakthroughs that are completely transforming healthcare.

Medicine and Neuroscience: This track will explore the future of biomedicine, neuroscience, and human enhancement and its impacts on human health and performance in six areas:

  • Stem cells and regenerative medicine: the emerging ability to repair, replace and regenerate damaged, aged, or diseased tissues utilizing cell therapies, therapeutic cloning, pluripotent stem cells, tissue engineering, biomaterials and artificial organs.
  • Targeted therapies, including minimally invasive medical devices, robotic surgery, designer drugs, identification and targeting of cancer stem cells.
  • Medical diagnostics and imaging: increasingly powerful and rapid imaging modalities, point- of-care medical diagnostics, nanomedicine and biomarker technology.
  • Neuroscience: neuroprosthetics (artificial retina, cochlear implants, brain-computer interfaces, deep brain stimulation), neuroplasticity, and direct fMRI functional brain imaging/scanning.
  • Wellness: preventative drugs, supplements/antioxidants/diet, proactive regimens, Internet- based medical informatics, and telemedicine.
  • Human enhancement: exoskeletons, robotic limbs, neuroenhancing pharmacological agents, gene therapy, and anti-aging strategies.

Nanotech: This track will cover the science, technology and potential future capabilities of nanotechnology, including:

  • Fundamental scaling laws and their limits.
  • The nature of atomically precise structures and computational chemistry.
  • Current and proposed manufacturing technologies including: lithography, microelectromechanical systems (MEMS), self assembly and positional assembly, DNA nanotechnology, nanomaterials, Scanning Probe Microscopy, mechanosynthesis, molecular positional devices, self replicating systems, molecular nanotechnology (MNT) and nanofactories.
  • Molecular computing, molecular logic elements, carbon nanotube electronics and thermal limits in computing.
  • Medical nanorobotics and nanomedicine.
  • The impact of nanotechnology on space, energy production and storage, national security, green manufacturing, environmental remediation and other areas.

Our law firm focuses on emerging medical and clinical therapeutic methods, and the laws and regulations that shape clinical practices and emerging models of care, whether they are biomedical or technological, or a hybrid of high-tech, high-touch. We advise and guide healthcare professionals and entrepreneurs on legal issues such as liability concerns (and liability risk management); the risk of professional discipline by state medical boards and other professional regulatory boards for providing new and emerging therapies and models of care; legal issues surrounding blended therapeutic approaches (such as medical spas which incorporate cosmetics and estheticians, and medicine and physicians); and state conflicts of interest laws (such as laws governing self-referral, kickbacks and fee-splitting).

Multi-disciplinary approaches to healthcare are the future. We will be seeing robots providing nursing and geriatric care; wearable computers that monitor our vital signs and provide micro-nutrients or other deliverables to regulate and optimize our metabolism; genetic upgrades, brain chips, and implanted enhancements; and wireless mind to mind communications.

Healthcare practices and clinics will be blending licensed and non-licensed healthcare providers and approaches that target nutrition, lifestyle, overall wellness, and technological routes to optimal health. Privacy and security will be at the forefront of patients’ legal concerns, and intellectual property concerns will dominate the legal landscape of providers and ventures.

The economic and financial shifts that healthcare reform will trigger may stimulate innovation and bring the provision of healthcare under a broader federal regulatory framework, but many areas of law will continue to operate and either constrain or support emerging clinical approaches to longevity and sustainable health. Contact our attorney team today.

Legal Strategy Session
Michael H Cohen Healthcare & FDA Lawyers

Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.

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