Home
Derivatives
Private Equity
Investment Funds
M&A
Investor Relations
Banking
Tax
Restructuring
Employment
Energy
Data & Technology
IP
Healthcare
Real Estate
Antitrust
Environment
Litigation
Terms
Privacy
Cookies
Pro Bono
Pay Transparency
Disclaimer
Alumni
Attorney Advertising

HEAD OF  DIVISION





MEDICAL  DEVICES

HEALTHCARE & SCIENCES

The health care industry in the 21st century faces tremendous change driven by growing demand, new technologies, shifting business models and intense government scrutiny.




Our healthcare lawyers help clients meet the challenges they face in today’s rapidly changing enforcement, regulatory, and scientific environments. McAllister Davis & Goldstein has deep substantive healthcare law expertise, unparalleled investigative experience, and a willingness and ability to try these cases to a jury if necessary. These skills have been brought to bear to achieve an extraordinary record of successful outcomes for our health care clients.

Our Clients

The comprehensive scope of the practice is unique: from helping to establish the start-ups developing the latest breakthrough drugs and medical devices, to defending pharmaceutical manufacturers in precedent-setting legal challenges, to counseling on the full spectrum of regulatory matters that these diverse entities face.

Many of our attorneys are scientists or engineers with degrees in relevant fields; our litigators hold degrees in physics, chemistry, pharmacology, molecular biology, biochemistry, and chemical engineering.

Transaction Expertise

The multi-disciplinary approach enables us to quickly assimilate our clients’ regulatory, intellectual property and commercial goals, identify potential issues and develop creative and novel approaches to maximize value for our clients.

We advise clients throughout a product’s life cycle, going beyond the traditional legal services offered by other firms to facilitate efficient and effective research and development, ensure successful launch and commercialization, and maximize the product’s franchise.
Whether guiding regulatory compliance, building strategic patent portfolios or prosecuting, defending and enforcing quality patents that consistently withstand challenges, we advise and represent life sciences leaders, healthcare companies and emerging innovators.

Our clients, spanning all industry sectors and ranging from startup ventures to multinational corporations and trade associations, trust us with their most challenging business problems.
They know that they can rely on McAllister Davis & Goldstein for practical, efficient solutions rooted in a sophisticated knowledge of their business that only comes from deep immersion in the industry and decades of dedicated service.
Our broad background and depth of experience ensures that when clients come upon a problem that they have not seen before or anticipated, chances are that we have.

Focus Areas include:

  • Healthcare: Our diverse client group includes hospitals, healthcare systems, medical centers, laboratories and others, whom we advise on clinical business.
  • Biotechnology & Pharmaceuticals: An international biotech and pharmaceuticals team, patent agents and science advisers address the inherent challenges of clients’ collective mission to cure disease and improve people’s health as well as the regulations that govern these pursuits in a wide range of areas.
  • Medical Device: In our comprehensive counsel to medical device startups, large manufacturers, research institutions, universities and others, we work with clients whose technologies span from cardiovascular and optics to renal care, lasers, surgical tools and more.

Healthcare Matters

Clients benefit from McAllister Davis & Goldstein’s deep experience in health care law, and our intimate knowledge of our clients’ industries, which position the firm to preempt and resolve legal issues across the full range of relevant practices. Our success in the courtroom in healthcare matters speaks for itself.

Telemedicine
German court classifies dermatology software

 
Pharmaceutical Policy
MEPs adopted their proposals to revamp EU legislation

 
Telemedicine

Court classifies dermatology software


Dermatology
Software: Class IIa
Medical Device (MDR)

ANDREA HUBER - MUNICH

Telemedicine is getting more and more relevant to the healthcare industry. However, telemedicine software providers often struggle with the classification of their software or apps under the Medical Device Regulation (EU) 2017/745 (MDR).

Recently, a decision by the Hanseatic Higher Regional Court Hamburg (OLG Hamburg, file reference: 3 U 3/24) has placed the spotlight on a dermatologic telemedicine app. Initially CE marked as a class I medical device following an EU declaration of conformity issued by its manufacturer, the app's classification was contested by a competitor.

In a landmark decision the Regional Court Hamburg decided that the app has to be classified as a class IIa medical device requiring the involvement of a notified body to conduct the conformity assessment procedure. The app in dispute is a telemedicine app which offers a digital skin-check allowing patients to submit skin condition images for diagnosis.
The decision has far-
reaching consequences
for the telemedicine
The patient takes pictures of their skin alteration and submits them using the platform of the app. Additionally, the patient answers an anamnesis form. A dermatologist examines the pictures and, if necessary, asks for additional information or pictures. If they have gathered sufficient information, they make a diagnosis and provide it to the patient.

The court classified this app as a class IIa medical device under rule 11 of Annex VIII of the MDR. Accordingly, software “intended to provide information which is used to take decisions with diagnosis or therapeutic purposes” qualifies at least as class IIa medical device. The court referred to the word “provide” which in their understanding also includes the mere transfer of information. It would not be necessary that information is generated by the app, e.g. that the software filters the pictures before it submits them to the doctor, to match the wording “provide”.

The court argues that the purpose of the MDR is to maintain a high standard of protection for human health. This purpose would not be fulfilled if software, like the one which was subject of the lawsuit, was not recognized as software which provides information and therefore would not be classified as a class IIa medical device. According to the Court the abstract risk for patients using telemedicine software is too high to classify such software in a lower risk class than IIa.

This judgment could significantly impact providers of telemedicine software, which would have to undergo a class IIa conformity assessment procedure involving a notified body. Nevertheless, there are also strong arguments to doubt the court's conclusions. In the previous instance the Regional Court of Hamburg decided to the contrary and ruled that a classification of the app as class I medical device was sufficient.
It is not only relevant that information is provided but who provides the information. Here the app only forwards the information, the provider however, is the patient. Critics point out that following the understanding of the Higher Regional Court every communication software that forwards diagnostic and therapeutic information would have to be classified as a class IIa medical device.

Therefore, the risk for the patients should not be considered from an abstract point of view. Rather, a concrete risk-based benchmark must be applied. The mere transfer of the pictures does not lead to a higher risk of misdiagnosis per se. Especially, because the dermatologist can demand further pictures if the quality or information is not yet to their content. Human misinterpretation could not be prevented through conformity assessment procedures.

According to the definition of the MDR, a medical device must have a medical purpose, as opposed to a purely general purpose.
It could be argued that a telemedicine software which only transfers information like a communication application only has such general purpose and therefore would not be classified as a medical device at all. German legal academics have criticized the Higher Regional Court for not addressing this issue at all.

The ruling has far-reaching consequences for the industry, potentially altering the regulatory landscape and affecting how telemedicine services are provided and managed. Providers of telemedicine software would have to conduct a lengthy and expensive class IIa MDR conformity assessment procedure following the decision. It remains to be seen whether other courts will follow the arguments of the Hanseatic Higher Regional Court Hamburg and decide in a similar way.
   Andrea Huber
    Healthcare & Sciences

   
  a.huber@mdg-lawyers.com
EU Pharmaceutical Policy
Parliament supports reform

ANDREAS MEIER - MUNICH

MEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines.

The EU Environment, Public Health and Food Safety Committee adopted its position on the new directive and regulation covering medicinal products for human use.

To reward innovation, MEPs want to introduce a minimum regulatory data protection period (during which other companies cannot access product data) of seven and a half years, in addition to two years of market protection (during which generic, hybrid or biosimilar products cannot be sold), following a marketing authorisation.
Pharmaceutical companies would be eligible for additional periods of data protection if the particular product addresses an unmet medical need (+12 months), if comparative clinical trials are conducted for the product (+6 months), and if a significant share of the product’s research and development takes place in the EU and at least partly in collaboration with EU research entities (+6 months). MEPs also want a cap on the combined data protection period of eight and half years.

A one-time extension (+12 months) of the two-year market protection period could be granted if the company obtains a marketing authorisation for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies.
European Parliament underlines the need to boost the research and development of novel antimicrobials, notably through market entry rewards and milestone reward payment schemes (e.g. early-stage financial support upon achieving certain R&D objectives prior to market approval). These would be complemented by a subscription model-based voluntary joint procurement scheme, to encourage investment in antimicrobials.
Among the new measures to promote the prudent use of antimicrobials, European Parliament want stricter requirements, such as restricting the prescriptions and dispensation to the amount required for the treatment and limiting the duration for which they are prescribed.

These new rules would require companies to submit an environmental risk assessment (ERA) when requesting a marketing authorisation. To ensure adequate evaluation of ERAs, European Parliament wants the creation, within the European Medicines Agency, of a new ad-hoc environmental risk assessment working party. MEPs insist that the risk mitigation measures (taken to avoid and limit emissions to air, water and soil) should address the entire life cycle of medicines.
   Andreas Meier
    Healthcare & Sciences

   
 a.meier@mdg-lawyers.com