Tag Archives: clinical trials

Blockchain: A Single, Immutable, Serialized Source of Truth

Last week MHL (Material Handling & Logistics) magazine publish a piece I wrote on the use of blockchain technology to provide high-value business benefits in supply chain management. Some of these include:

  • Creation of an immutable, portable record of all hand-offs between parties that is not held hostage by any one vendor or party
  • Complete, portable chain-of-custody useful for every from regulatory compliance to management of product recalls
  • (My favorite): Use of Smart Contracts to create distributed automated intelligence to do things like automatically triggering notifications and invoicing on milestone achievements (CFOs would love that). This could be accelerated even faster by using smart sensors.

My focus was on ideas that can truly be implement today, integrating with existing systems for milestone management and payment processing (easing adoption and integration). Please visit the MHL magazine to read the full article. You can also download the infographic they have hosted with the article here.

BTW, these same concepts can be applied anywhere serialization is needed: digital media sales, regulated product delivery, clinical trials, etc.

Fun fact: You can likely guess when I originally wrote the article based on the BTC price quoted for the music download. BTC has appreciated quite a bit since then. 😉

Low-risk, high-value Health 2.0 ideas: An introduction

Adoption of social media for health care has been understandably slow

Over the past three years, use of social networking to transform business (i.e., Enterprise 2.0) and government (i.e., Gov 2.0) has been very hot. However, use of these same technologies to transform health care (i.e., Health 2.0) has been decidedly slower.

The reason is simple: all members of the health care industry – regardless of whether they are public, private and not-for-profit – are bound by a much wider set of regulations regarding the control and access of information than nearly any other industry sector. (Click here to see my prior blog post for a deeper discussion of these.) These regulations are not bad; rather, they are paramount. They assure scientific integrity, safety and privacy—things no one wants to do without.


The way is to avoid the largest risks: Manage the flow of information

Health care is an incredibly collaborative sector. As such, use of social networking to foster information exchange presents enormous opportunities to improve both global health and a huge part of the industrialized world’s economy.

risk_180pxThe key to success is to use social networking in ways that taps collaboration and creatively while avoiding risks of data contamination or disclosure of everything from private health information to unverified or even false information. This can be done by strictly controlling the flow of information:

  • Separate patient, clinical trial subject and pharmacovigilance data from social networks. Instead leverage social networks to share only structured documents (e.g., Protocols and Informed Consent Forms) or operational data (e.g., clinic visit scheduling)
  • Wherever possible, replace unstructured with structured interaction to eliminate opportunities to share patient- and subject-specific data where it is not appropriate. Also limit the types of interactions available—especially on networks that include patients or clinical trial subjects.
  • When unstructured interaction is absolutely required, combine Access Controls and Pre-Publication Moderation to guard against inappropriate disclosure of privacy or safety data. Also ensure you employ strong authentication and audit trails to ensure even moderated user-generated content is regulatory compliant.

Four high-value ideas that do this

At this point, you may be asking if social networking can create value while adhering to the above risk avoidance approaches. It can. Here are four examples for BioPharma Social Networking business services that I put together in collaboration with experts from four different health care industry organizations:

  1. Clinical Trial enrollment and participation service
  2. Clinical Trial subject alert and reminder service
  3. Principal Investigator update and notification service
  4. Therapeutic area-based Key Opinion Leader (KOL) networks

In the coming months, I will post an entry outlining both the drivers for each of these services and a top-level overview as to how each could work.